[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-reconstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-reconstruction":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,44,77,110,135,163,183,209,228,251,273,298,321,344,369,390,415,438,463,490,513,534,554,574,594],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100644558","orasis-in-breast-reconstruction-100644558",false,"NCT07670754","ORASIS in Breast Reconstruction","ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial","Inclusion:\n\n* Female Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction patients who have received a prior mastectomy (either unilateral or bilateral) on the breast undergoing reconstruction\n* Patients who received mastectomies for oncologic or prophylactic indications\n* Patients receiving either immediate or delayed DIEP flap breast reconstruction\n* Age 18 or older at the time of patient consent and DIEP flap surgery\n\nExclusion:\n\n* History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction\n* Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction\n* Under the age of 18 at the time of patient consent or DIEP flap surgery","FEMALE","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon efficiency, and anastomosis outcomes. The investigators hypothesize that the use of ORASIS will decrease the amount of time needed to perform microsurgical anastomoses, reduce interruptions for irrigation and suction, and increase the quality of anastomoses in DIEP flap breast reconstruction.",[27,28,29],"DIEP Flap","Breast Reconstruction","Breast Cancer",[27,28,29],"NOT_YET_RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":21},"2026-12",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Duke University","OTHER",2,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100645162","a-post-market-prospective-clinical-study-of-eurosilicone-luna-mammary-implants-100645162","NCT07679594","A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants","A Prospective, Multi-centre, Observational, Non-comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone LunaXT Range of Silicone Breast Implants When Used in Breast Implantation.","Inclusion Criteria:\n\n* The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.\n\nInclusion criteria are:\n\n1. Genetic female subjects aged between 18 and 65 years old.\n2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:\n\ni. Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs (synthetic or natural).\n\nii. Primary breast augmentation (cosmetic surgery) with or without mastopexy iii. Breast revision surgery with or without mastopexy c) Subjects who have received a Eurosilicone Luna implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow-up appointments as per the study protocol.\n\nExclusion criteria are:\n\n1. Subjects with a BMI \\>35.\n2. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.\n3. Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer-related clinical studies.\n4. Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.\n5. Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.\n6. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.\n7. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.\n8. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.\n9. Subjects with a known history of compromised wound healing.\n10. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.\n11. Women who are pregnant and\u002For current breast feeders who do not stop breast feeding within 3 months of getting breast implants.\n12. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant.",true,"65 Years",{"count":54,"type":21},650,"OBSERVATIONAL","The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.",[58,28,59,60,61,62],"Breast Augmentation","Breast Revision-Augmentation","Breast Reconstruction With Silicone Implants","Breast Reconstruction, Revision Breast Reconstruction","Breast Augmentation and Breast Reconstruction",[64,65,66],"Luna XT","Anatomical breast implant","Mammary implant","RECRUITING","2026-06-25",{"date":34,"type":35},{"date":71,"type":35},"2026-03-30",{"date":73,"type":21},"2038-12-31",{"name":75,"class":76},"GCA (Eurosilicone)","INDUSTRY",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":85,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100517128","post-market-prospective-clinical-study-of-nagor-perle-mammary-implants-100517128","NCT06013514","Post-market Prospective Clinical Study of Nagor Perle Mammary Implants","A Prospective, Multi-center, Observational, Non Comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation","PERLE10PMCF","Inclusion Criteria:\n\n1. Genetic female subjects aged ≥18 and ≤65\n2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-\n\ni) Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs of animal origin (bovine, porcine)). ii) Primary breast augmentation (cosmetic surgery) with or without mastopexy iii) Breast revision surgery with or without mastopexy c) Subjects who have received a Nagor PERLE implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow up appointments as per the study protocol.\n\nExclusion Criteria:\n\n1. Subjects undergoing implant augmentation with a BMI \\> 30 and undergoing reconstruction with a BMI \\>32.\n2. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.\n3. Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies.\n4. Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.\n5. Subjects who have ADMs of synthetic origin.\n6. Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.\n7. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.\n8. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.\n9. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.\n10. Subjects with a known history of compromised wound healing.\n11. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.\n12. Women who are pregnant and\u002For current breast feeders who do not stop breast feeding within 3 months of getting breast implants\n13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant",{"count":86,"type":21},60,"Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.\n\nThis study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant.\n\nThe two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter.\n\nThe study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications",[28,89,90,58,60,91,92,93],"Breast Reconstruction Following Mastectomy","Breast Revision","Breast Reconstruction After Mastectomy","Breast Reconstruction Surgery","Breast Implants",[95,96,97,98,99,100,101,102],"prospective","observational","non-comparative","post-marketing study","PMCF","Perle","Nagor","GCA",{"date":32,"type":35},{"date":105,"type":35},"2024-06-01",{"date":107,"type":21},"2038-09",{"name":75,"class":76},1,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":133,"locationsCount":109},"100493864","bioimpedance-measurement-of-abdominal-free-flaps-during-arterial-and-venous-weaning-in-breast-reconstruction-100493864","NCT05710705","Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction","MONITRANS2","Inclusion Criteria:\n\n* Woman undergoing microsurgical breast reconstruction using a free abdominal flap\n* Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Pregnant patient\n* Patient with an active implantable device such as a pacemaker or an artificial heart\n* Patient refusing to participate in the study\n* Age less than 18 years old",{"count":118,"type":21},10,[24],"As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.\n\nThe patients will benefit from an \"improved\" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.\n\nThis protocol is therefore a feasibility study for the collection of data of interest.",[28,122,123],"Thrombosis, Venous","Bioimpedance Measurement Capacity",[125,122,126],"breast reconstruction","bioimpedance measurement capacity","2026-06-23",{"date":129,"type":35},"2026-06-24",{"date":131,"type":35},"2022-12-08",{"date":37,"type":21},{"name":134,"class":42},"Centre Hospitalier Universitaire, Amiens",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":109},"100599440","phase-3-hypofractionated-vs-conventional-rt-after-prosthetic-breast-reconstruction-100599440","NCT07084519","Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction","Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction","Inclusion Criteria:\n\n* Female, aged 18-75 years\n* Karnofsky Performance Status ≥60\n* Histopathologically confirmed invasive breast adenocarcinoma\n* Total mastectomy \\[with or without nipple-areolar complex preservation\\] + axillary dissection\u002Fsentinel lymph node biopsy + implant\u002Fexpander placement R0 resection with negative margins\n* pT3 or N2-3 disease; or pT1-2N1\n* No distant metastasis\n* Completed standard neoadjuvant\u002Fadjuvant chemotherapy cycles\n* ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to chest wall or nodal regions\n* Pregnancy or lactation\n* T4 stage disease\n* Autologous breast reconstruction of the irradiated breast\n* Pre-radiotherapy local\u002Fregional\u002Fdistant metastasis\n* Grade ≥3 implant-related adverse events irreversible before radiotherapy\n* Bilateral breast cancer requiring bilateral radiotherapy\n* Concurrent\u002Fsecondary malignancy with disease-free interval \\\u003C5 years \\[except non-melanoma skin cancer, papillary\u002Ffollicular thyroid cancer, or cervical carcinoma in situ\\]\n* Active collagen vascular disease, e.g., SLE, scleroderma\n* Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders","75 Years",{"count":144,"type":21},506,[146],"PHASE3","This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.\n\nStudy Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.\n\nIntervention:\n\nHFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy\u002Ffraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy\u002Ffraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)",[29,28,149],"Radiation Oncology",[151,152,153],"breast cancer","prosthetic breast reconstruction","hypofractionated radiotherapy","2026-06-17",{"date":156,"type":35},"2026-06-22",{"date":158,"type":35},"2026-03-27",{"date":160,"type":21},"2030-12-31",{"name":162,"class":42},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":109},"100430932","a-comparative-analysis-of-revolve-lipografter-and-viality-in-autologous-fat-grafting-during-breast-surgery-100430932","NCT04891510","A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery","Inclusion Criteria:\n\n* Female;\n* Documented history of previous breast surgery (either complete or partial mastectomy);\n* Available harvest sites for fat grafting as documented by plastic surgeon;\n* BMI \\> 20;\n* Anticipated harvested fat volume \\> 50cc;\n* Competency and willingness to provide consent\n\nExclusion Criteria:\n\n* Suspected or known to be pregnant",{"count":170,"type":21},135,[24],"The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.",[174,175,28],"Mastectomy","Mammaplasty",{"date":156,"type":35},{"date":178,"type":35},"2021-05-19",{"date":180,"type":21},"2028-06-01",{"name":182,"class":42},"Weill Medical College of Cornell University",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":205,"leadSponsor":207,"locationsCount":109},"100643509","autologous-fat-grafting-for-total-breast-reconstruction-in-irradiated-breast-cancer-patients-100643509","NCT07641985","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients","AFT-R","Inclusion Criteria:\n\n* Female, aged \\>18 years.\n* BMI between \\> 22 and \\\u003C35 kg\u002Fm2\n* History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).\n* May include contralateral\u002Fbilateral prophylactic mastectomy if at least one side had cancer and radiation.\n* Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.\n* Medically fit for surgery (ASA I-III).\n* Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).\n* No evidence of active cancer at enrollment; remission confirmed.\n* Able to wear the EVE device (if randomized in AFT).\n* Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.\n\nExclusion Criteria:\n\n* Prior autologous breast reconstruction on the intended side. BMI \\\u003C22 or \\>35 kg\u002Fm2\n* Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).\n* Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).\n* Current chemotherapy or completed less than 4 weeks prior to enrollment.\n* Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).\n* Active smoker or not abstinent for at least 6 weeks pre-operatively.\n* Pregnant at time of enrollment.\n* In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).\n* Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).\n* Allergy to lidocaine or silicone",{"count":192,"type":21},280,[24],"The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are:\n\nDoes AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients?\n\nResearchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients.\n\nParticipants will:\n\nUndergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation",[29,28,91,196,197],"Breast Cancer Radiation","Lipofilling",[197,199,200],"Breast reconstruction","Irradiated patients","2026-06-09",{"date":203,"type":35},"2026-06-11",{"date":34,"type":21},{"date":206,"type":21},"2032-07-01",{"name":208,"class":42},"Maastricht University Medical Center",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100637888","custom-breast-implants-with-3d-imaging-100637888","NCT07628517","Custom Breast Implants With 3D Imaging","Personalized Breast Implant Modeling Using Imaging Techniques (MRI and Vectra)","Inclusion Criteria:\n\n* The targeted patients will be those undergoing mastectomy following neoadjuvant chemotherapy, prophylactically, or in the context of lobular cancer.",{"count":7,"type":21},"The aim of this study is to use MRI and Vectra metadata from patients in order to develop the \"customizable\" aspect of the MyBREAST One implant through computer modeling of this implant based on the collected metadata.",[175,28],"2026-06-04",{"date":221,"type":35},"2026-06-05",{"date":223,"type":21},"2026-05-18",{"date":225,"type":21},"2027-04",{"name":227,"class":42},"HELMo Link asbl",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":43},"100625086","evaluation-of-the-impact-of-pre-habilitation-using-physiotherapy-and-mechanical-stimulation-on-shoulder-pain-and-mobility-in-patients-undergoing-breast-reconstruction-using-a-latissimus-dorsi-flap-100625086","NCT07418060","Evaluation of the Impact of Pre-habilitation Using Physiotherapy and Mechanical Stimulation on Shoulder Pain and Mobility in Patients Undergoing Breast Reconstruction Using a Latissimus Dorsi Flap","Randomized, Multicentre Study Evaluating the Impact of Pre-habilitation Using Physiotherapy and Mechanical Stimulation on Shoulder Pain and Mobility in Patients Undergoing Breast Reconstruction Using a Latissimus Dorsi Flap","PREHAB KINELGD","Inclusion Criteria:\n\n* Female patient aged 18 years or older\n* Scheduled for breast reconstruction with a latissimus dorsi flap following breast cancer\n* Patient has been informed and has signed the informed consent form\n* Affiliated with a social security system\n\nExclusion Criteria:\n\n* Patient with pre-existing shoulder pathology (Constant score \\\u003C 80\u002F100)\n* Patient with uncontrolled psychiatric or mental disorders\n* Patient unable to understand French",{"count":237,"type":21},72,[24],"Each year in France, nearly 59,000 new cases of breast cancer are diagnosed, and approximately 22,000 mastectomies are performed. Among these patients, 30% choose to undergo breast reconstruction. Breast cancer leads to numerous physical and psychological changes. The need to strengthen patient support around breast reconstruction has been highlighted, and it is one of the priorities of the national Ten-Year Cancer Control Strategy. The growing number of patients living after cancer makes the management of post-treatment sequelae essential.\n\nThe rate of reconstruction is increasing thanks to improvements in technique and better access to information. Among the available options, the latissimus dorsi (LD) flap has been a standard technique for immediate and delayed breast reconstruction for over 25 years. The LD technique offers several advantages: high reliability, feasibility even in irradiated thoraxes, low rates of postoperative complications, and satisfactory aesthetic outcomes. Its versatility and reliability have made it a cornerstone of breast surgery. However, this technique can lead to short- and long-term functional sequelae, which persist in 10% of patients. To reduce these side effects, an optimized version-the lipofilled mini-latissimus dorsi flap (mLD)-was developed by a team in Strasbourg. This quicker and less muscle-invasive technique is mainly used for immediate reconstruction or to replace implant-based reconstruction, with systematic lipofilling. However, no objective functional assessment of this method has yet been carried out, justifying a stratification according to the type of procedure for randomization in future studies. According to a prospective Icelandic study involving 15 patients, full recovery can be expected, but patients must be informed of the time and effort required to achieve it. The authors also concluded that further research is necessary to better understand the limits of long-term recovery.\n\nA study of 450 LD reconstructions showed that pain and the main functional sequelae were located in the back and shoulder, with 10% of patients experiencing significant long-term pain. In addition, according to this study, around 40% of patients consider postoperative sequelae and scarring burdensome. However, regret rates remain low, at under 3%.\n\nIn view of these findings, preventing pain and functional impairment has become a key research focus to improve patients' quality of life.\n\nPostoperative rehabilitation plays a crucial role in managing pain, reducing functional impairment, and optimizing aesthetic outcomes. The addition of mechanostimulation (MS) has been shown to improve scar appearance, shoulder function, and functional well-being compared with rehabilitation alone. MS is delivered using a device equipped with motorized rollers and suction to mobilize tissues. In physiotherapy, it helps relieve pain and improve mobility.\n\nPrehabilitation, a rapidly expanding concept in surgery, aims to prepare patients before their procedure. However, to date, no prehabilitation approach combining physiotherapy and MS has been considered prior to LD flap surgery. One study highlighted improved tissue trophicity after tissue preparation with MS before lipomodelling.\n\nThe objective of our study is to evaluate the benefit of prehabilitation through physiotherapy incorporating MS to prepare tissues (in particular skin and muscle) on shoulder pain and functional outcomes in patients undergoing breast reconstruction with a latissimus dorsi flap.\n\nAdditionally, due to the heterogeneity and sometimes limited access to specialized postoperative physiotherapy, extensive patient follow-up has been planned in order to describe, on an exploratory basis, real-world rehabilitation practices.",[29,241,28,242],"Physiotherapy","Latissimus Dorsi Flap","2026-06-02",{"date":219,"type":35},{"date":246,"type":21},"2026-08",{"date":248,"type":21},"2029-05",{"name":250,"class":42},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":259,"maxAge":142,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":43},"100603367","effectiveness-and-safety-of-ovitex-prs-in-breast-reconstruction-100603367","NCT07135596","Effectiveness and Safety of OviTex® PRS in Breast Reconstruction","Research on the Effectiveness and Safety of Treatment With OviTex® PRS - a Breast Reconstruction Evaluation","RESTORE","Inclusion Criteria:\n\n1. Patient is a female between the ages of 22 - 75, inclusive, at the time of enrollment (e.g. date of index surgical procedure);\n2. Patient is planned for a first-time immediate unilateral or bilateral DTI pre-pectoral breast reconstruction following mastectomy for cancer or as cancer prophylaxis;\n3. Patient is not a current cigarette smoker;\n4. Patient is willing and able to voluntarily sign the IRB approved Subject Informed Consent Form;\n5. Patient is willing and able to comply with the study requirements including completion of required follow-up visits, subject questionnaires, clinic evaluations, and photographs.\n\nExclusion Criteria:\n\n1. Patient has a BMI \\\u003C 18.5 or \\> 35;\n2. Patient is undergoing radical mastectomy;\n3. Breast reconstruction plan includes hybrid implant coverage using another type of mesh (synthetic or ADM) or another autologous treatment such as large latissimus flap, abdominal flap or similar;\n4. Breast reconstruction plan includes a custom sized breast implant, permanent breast implant greater than 800cc, and\u002For a permanent breast implant that is not FDA approved for use in breast reconstruction;\n5. Patient has undergone prior breast reconstruction, breast augmentation, mastopexy, or breast reduction surgeries (not including breast biopsy);\n6. Patient is undergoing delayed reconstruction;\n7. Patient has received neo-adjuvant radiation to the chest (including any previous history of whole breast radiation or mantle radiation);\n8. Patient has received neo-adjuvant chemotherapy within the 4 weeks prior to enrollment;\n9. Patient has received Keytruda therapy or is planning to receive Keytruda therapy during study participation;\n10. Patient has uncontrolled Type I or Type II diabetes (HbA1C \\>7%);\n11. Patient is pregnant or planning to become pregnant during study participation and up to 5 years from the index surgical procedure;\n\n    • If the subject is not post-menopausal, agree to take adequate birth control precautions during study participation;\n12. Patient has been diagnosed with a medical condition or is taking medications which are known to impact wound healing, weaken the body's natural resistance to disease, result in elevated postoperative risks, or may otherwise affect the validity of the study;\n13. Patient has a known sensitivity or allergy to poly(lactic-co-glycolic acid) (PLGA) or materials of ovine (sheep) origin;\n14. Patient is diagnosed with a bleeding disorder in which medication is not stopped within 2 weeks of the index procedure;\n15. Patient is currently diagnosed with drug or alcohol abuse or has a known history with relapse within the past 3 years;\n16. Patient is currently participating in another drug or device clinical trial;\n17. Patient is currently imprisoned.\n\nIntraoperative Exclusion Criteria\n\nAll subjects will be evaluated intraoperatively for the following exclusion criteria:\n\n1. Subject does not receive an immediate pre-pectoral direct-to-implant breast reconstruction;\n2. Study device will not be used during the procedure or a non-eligible device will be implanted.","22 Years",{"count":261,"type":21},235,[24],"The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.",[28],"2026-05-29",{"date":243,"type":35},{"date":268,"type":35},"2026-04-10",{"date":270,"type":21},"2034-06",{"name":272,"class":76},"Tela Bio Inc",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":109},"100610665","evaluation-of-wellbeing-and-patient-reported-outcomes-after-open-vs-robotic-mastectomy-with-diep-reconstruction-100610665","NCT07230535","Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction","A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction","REBORN","Inclusion Criteria:\n\n* Women aged 18 years and older\n* Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications:\n\n  1. Genetic mutation carriers undergoing risk-reducing mastectomy.\n  2. Ductal carcinoma in situ (DCIS) requiring mastectomy.\n  3. Early invasive breast cancer requiring mastectomy.\n  4. For those considered for Nipple Sparing Mastectomy randomisation arms the tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).\n* Candidates for immediate breast reconstruction with DIEP reconstruction\n* Fluent in English\n* Fit for general anaesthetic\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms\n* Nipple involvement for Nipple Sparing Mastectomy Arms.\n* Prior chest wall radiation therapy\n* Pregnancy\n* Lactation\n* Patients with insufficient English to sign an informed consent (i.e. interpreter required).",{"count":282,"type":21},250,[24],"Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques. Its use has expanded in both therapeutic and risk-reducing settings, including ductal carcinoma in situ (DCIS) and early-stage invasive breast cancer, where the NAC is not clinically or radiologically involved. Multiple observational and cohort studies support the oncological safety of NSM in appropriately selected patients, provided meticulous surgical technique and pathological assessment are employed to minimise the risk of residual disease.\n\nRobotic-assisted NSM has emerged as a minimally invasive alternative to conventional open techniques. Robotic platforms offer enhanced three-dimensional visualisation, improved instrument articulation, and ergonomic advantages that may facilitate precise dissection while reducing surgeon fatigue. Single-port robotic systems enable NSM to be performed through a single axillary incision, potentially reducing visible scarring and postoperative discomfort while maintaining oncological principles. Early series from high-volume centres have demonstrated the technical feasibility and short-term safety of robotic NSM, with outcomes broadly comparable to open NSM and signals of potential aesthetic benefit. However, these data are largely non-randomised and derived from single-centre experiences.\n\nDespite the increasing adoption of both conventional and robotic NSM, there remains a paucity of high-quality prospective evidence evaluating patient-reported outcomes (PROs). Validated instruments such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) provide robust measures of patient satisfaction, psychosocial well-being, and aesthetic outcome, yet randomised comparisons of robotic versus open NSM using these tools are lacking. In particular, there is limited evidence examining whether the proposed cosmetic and experiential advantages of robotic surgery translate into meaningful improvements in PROs across different reconstructive pathways.\n\nBreast reconstruction is a critical determinant of postoperative quality of life following mastectomy. Both implant-based reconstruction and autologous reconstruction using deep inferior epigastric perforator (DIEP) flaps are established techniques, each with distinct risk profiles, recovery trajectories, and long-term outcomes. Autologous DIEP reconstruction is associated with superior long-term satisfaction and physical well-being in many patients, while implant-based reconstruction remains the most commonly performed approach nationally. Evaluating NSM techniques across both reconstructive modalities enhances the generalisability and clinical relevance of trial findings.\n\nThe REBORN Network Trial is a multicentre, randomised controlled study conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. Patients undergoing mastectomy with immediate reconstruction are stratified by reconstruction type (implant-based or DIEP flap) and randomised to receive either robotic-assisted or conventional open NSM. Robotic procedures are centralised within a designated surgical hub, while open procedures are delivered either locally or centrally, depending on reconstructive requirements. This design enables equitable access to robotic surgery while maintaining oncological safety and surgical expertise.\n\nBy comparing robotic-assisted and open NSM within both implant and DIEP reconstruction cohorts using validated PRO measures, this study aims to determine whether robotic technology confers measurable benefits in patient satisfaction, body image, and aesthetic outcome. The findings will inform patient counselling, surgical decision-making, and future service development within networked breast cancer care systems.",[286,28,287,288],"Breast Cancer, Breast Neoplasms","DIEP Flap Breast Reconstruction","Robotic Surgery","2026-05-28",{"date":291,"type":35},"2026-06-01",{"date":293,"type":35},"2025-12-01",{"date":295,"type":21},"2029-12-31",{"name":297,"class":42},"Beaumont Hospital",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":320},"100560288","phase-3-evaluation-of-the-safety-and-effectiveness-of-artia-reconstructive-tissue-matrix-breast-reconstruction-adora-in-adult-participants-100560288","NCT06575192","Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants","A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy","Inclusion Criteria:\n\n* Participants who will undergo unilateral or bilateral mastectomy upon enrollment.\n* Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA.\n\nExclusion Criteria:\n\n* Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.\n* Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.",{"count":306,"type":21},264,[146],"The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.",[28],[28,311,312],"ADORA","ARTIA",{"date":291,"type":35},{"date":315,"type":35},"2024-11-05",{"date":317,"type":21},"2031-02",{"name":319,"class":76},"AbbVie",22,{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":109},"100484259","pulsed-lavage-in-implant-based-breast-reconstruction-100484259","NCT05585710","Pulsed Lavage in Implant-Based Breast Reconstruction","Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial","Inclusion Criteria:\n\n* Female\n* Between 18 and 75 years of age, inclusive\n* Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy\n* Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document\n\nExclusion Criteria:\n\n* Male\n* \\\u003C 18 years of age or \\> 75 years of age\n* Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy",{"count":329,"type":21},62,[24],"To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.",[28],[125,334,335],"implant-based breast reconstruction","pulsed lavage","2026-05-14",{"date":223,"type":35},{"date":339,"type":35},"2024-03-01",{"date":341,"type":21},"2027-08",{"name":343,"class":42},"University of Alabama at Birmingham",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":109},"100603721","hyperbaric-oxygen-therapy-to-improve-autologous-fat-graft-intake-in-irradiated-breast-100603721","NCT07140198","Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast","Prospective Study to Evaluate the Effectiveness of Hyperbaric Oxygen Therapy (HBOT) to Increase the Survival of Autologous Fat Transfer for Breast Reconstruction After Radiotherapy: A Randomized Controlled Phase II Cross-over Trial","Inclusion Criteria:\n\n* Adult (18 y.o. or more) female patients considered for lipofilling following breast reconstruction in an oncological setting which received radiation therapy on the affected breast.\n* Ability to provide informed consent, documented by signature\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Unability to provide informed consent\n* Previous enrolment into the current investigation\n\nContra-indication to HBOT :\n\n* Anamnestically reported spontaneous pneumothorax\n* Status post-thoracotomy\n* Significant intra-pulmonary lesions (including emphysematous bullae)\n* Respiratory function disorders (both obstructive and restrictive syndromes)\n* Pregnancy\n* Major psychiatric disorders\n* Uncontrollable claustrophobic reaction\n* Seizures, even if treated and asymptomatic for some time\n* Status post-severe traumatic brain injury with neurological deficits and seizures\n* Decompensated heart failure\n* Recent myocardial infarction (\\\u003C6 months) or with persistent hemodynamic sequelae\n* Spastic coronary angina\n* Cardiac arrhythmias, atrioventricular block, Wolff-Parkinson-White syndrome, sinus node dysfunction, Lown-Ganong-Levine syndrome\n* Cardiac pacemakers with unknown pressure resistance\n* Severe bradycardia\n* Sinus ostium displacement (acute or chronic)\n* Displacement of the auditory canal entrance (acute or chronic)\n* Status post-tympanoplasty type I-III \\\u003C3 months\n* Acute febrile state\n* Optic neuritis\n* Unstabilized hyperthyroidism\n\nContra-indication to MRI :\n\n* Non-MRI-compatible pacemaker, cochlear implant, drug-infusion pump or neurostimulator.\n* Metallic foreign body in critical area (eye, brain, etc.)\n* Ferromagnetic vascular surgical clips of older generation, e.g., for intracranial aneurysm repair.",{"count":352,"type":21},16,[24],"The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) enhances fat graft survival in lipofilling procedures in irradiated breast cancer patients. The main questions it aims to answer are:\n\nDoes it improve fat graft survival ? Evaluate safety and tolerability of HBOT in this setting? Researchers will compare patient receiving HBOT to a control group without HBOT to see if.\n\nSixteen female patients will undergo two autologous fat grafting sessions: one with HBOT and one without, in a randomized sequence. Patients will undergo three MRI during the study to evaluate the fat retention rate.",[28,197,356],"Hyperbaric Oxygen Therapy",[125,358,359,360],"Irradiation","hyperbaric oxygen therapy","lipofilling","2026-05-11",{"date":336,"type":35},{"date":364,"type":35},"2026-03-01",{"date":366,"type":21},"2028-12",{"name":368,"class":42},"University Hospital, Geneva",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":51,"sex":17,"minAge":259,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":387,"locationsCount":389},"100551166","acellular-dermal-matrix-investigation-in-breast-reconstruction-100551166","NCT06456554","Acellular Dermal Matrix Investigation in Breast Reconstruction","ADMIRE","Inclusion Criteria:\n\n* Genetic female\n* Age 22 or older at time of consent\n* Undergoing immediate breast reconstruction\n* 2 stage breast reconstruction using pre pectoral technique\n* Nipple or skin sparing mastectomy\n* Willing and capable of providing informed consent\n* Able to comply with study requirements\n\nExclusion Criteria:\n\n* Planned concurrent reconstruction with pedicled flaps or free tissue\n* Pregnant or breast feeding\n* Investigator has determined tissue is unsuitable for two-stage breast reconstruction\n* History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis\n* Any serious and\u002For unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator\n* Vulnerable subject populations\n* Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study\n* Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall\n* Active abscess or infection in the intended reconstruction site\n* Residual gross tumor at the intended reconstruction site\n* Active use of any tobacco\u002Fnicotine products\n* Has body mass index (BMI) \\>35\n* Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure\n* Is currently taking medications including systemic steroids",{"count":377,"type":21},467,[24],"Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.",[28],"2026-04-29",{"date":383,"type":35},"2026-04-30",{"date":385,"type":35},"2024-11-22",{"date":39,"type":21},{"name":388,"class":76},"RTI Surgical",13,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":398,"maxAge":399,"enrollmentInfo":400,"targetDuration":402,"studyType":55,"phases":4,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":109},"100558783","evaluation-of-safety-of-acellular-dermal-matrixadm-in-breast-reconstruction-100558783","NCT06555614","Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction","Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants","ADM","Inclusion Criteria\n\nProspective Subjects (Test Group):\n\n* Female patients aged 19 to 79 years\n* Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer\n* Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits\n\nRetrospective Medical Record Collection (Control Group):\n\n* Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital\n* Availability of medical records between March 1, 2021, and March 31, 2024\n\nExclusion Criteria\n\nProspective Subjects (Test Group):\n\n\\- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments)\n\nRetrospective Medical Record Collection (Control Group):\n\n\\- Patients with no recorded follow-up visits after application of the acellular dermal matrix","19 Years","79 Years",{"count":401,"type":21},120,"12 Weeks","The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.",[405,28],"Breast Cancer Female","2026-04-23",{"date":408,"type":35},"2026-04-28",{"date":410,"type":35},"2024-06-13",{"date":412,"type":21},"2027-02-28",{"name":414,"class":76},"DOF Inc.",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":109},"100613300","phase-1-assessment-of-topical-minoxidil-on-intraoperative-flap-perfusion-and-cutaneous-flap-viability-in-breast-recon-100613300","NCT07264790","Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon","Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction","Inclusion Criteria:\n\n1. Female sex \\> 18 years old\n2. Genetic predisposition to cancer\n3. Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction\n4. Capable of giving informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of breast cancer\n2. History of cancer\n3. Currently pregnant or planning to be pregnant (for women of child-bearing potential)\n4. Male sex",{"count":7,"type":21},[424],"PHASE1","The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at the time of surgery. Patients will undergo randomization of their breasts to determine which breast will receive the experimental intervention and which breast will serve as the internal control (receive placebo). The experimental breast will receive the novel pharmacologic delay treatment, 5% minoxidil, while the internal control breast will receive the current standard of care, which does not include any topical application prior to surgery - a placebo control will be used.\n\nThis will be a triple-blind study, where both the participants and investigators will be blinded to which breast will receive the intervention. The patients will receive two bottles \"compound A\" and \"compound B\" with directions from the pharmacy for which compound to apply to each breast.\n\nProduct will be applied for 2 weeks prior to planned surgery. Surgery will proceed without any changes to standard practice.",[28,427,428,429],"Perfusion; Complications","High Risk for Breast Cancer","Genetic Predisposition","2026-04-01",{"date":432,"type":35},"2026-04-06",{"date":434,"type":21},"2026-04",{"date":436,"type":21},"2027-09",{"name":41,"class":42},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":459,"leadSponsor":461,"locationsCount":109},"100629880","clinical-evaluation-of-neorepair-acellular-matrix-in-immediate-implant-based-breast-reconstruction-100629880","NCT07480421","Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction","Neo-Matrix","Inclusion Criteria:\n\n* Provide written informed consent;\n* Female sex at birth;\n* Be 18 years of age or older;\n* Have an indication for reconstructive surgeries requiring reinforcement, repair, regeneration, and reconstruction of tissues in the breast region;\n* Have well-vascularized tissue, according to the physician's clinical assessment, for better cell infiltration, revascularization, and incorporation;\n* Have an indication for breast reconstruction with Silimed acellular matrix intended for subcutaneous or submuscular implantation;\n* Have an indication for breast reconstruction with Silimed breast implants;\n* Have the ability to comply with the protocol for the entire follow-up period.\n\nExclusion Criteria:\n\n* Breast augmentation without reconstruction in at least one breast;\n* Neoplasia of any type that is not yet treated, or is under treatment, or requires surgical removal at the time of implantation\\*;\n* Pregnancy or breastfeeding at the time of implantation;\n* Smoking, uncontrolled diabetes, obesity (grade 2 or higher) or ASA (American Society of Anesthesiology) pre-surgical classification III\u002FIV (ANNEX I);\n* Active infection that is not yet treated or is under treatment at any site at the time of implantation;\n* Active inflammation that is not yet treated or is under treatment at the implantation site;\n* Report or record of adverse reactions or intolerance or known history of hypersensitivity to collagen or bovine products at the time of implantation;\n* Report or record of adverse reactions or intolerance to silicone;\n* Any immune disorder or disease at the time of implantation;\n* Depressed immune system at the time of implantation;\n* Report or record of atopy at the time of implantation;\n* Record or report of use of illicit drugs or medications that increase the risk of immediate post-surgical complications (e.g., medications that interfere with coagulation);\n* High surgical risk or risk of complications in the immediate post-surgical period estimated before implantation;\n* Evidence or report of tissue characteristics that are clinically incompatible with successful implantation (e.g., tissues with excessive fibrosis or compromised vascularization);\n* Having participated in another clinical study up to 6 months before matrix placement, unless the investigator judges it to be beneficial for the participant and not impacting the study;\n* Any other condition that, based on the opinion of the investigator or designated individual, may prevent the provision of informed consent, make participation in the study unsafe, compromise adherence to the protocol, complicate the interpretation of outcome data, or otherwise interfere with the achievement of the study objectives.\n\n  * Breast neoplasia where part of the treatment involves an initial surgical approach does not constitute an exclusion criterion, provided that this treatment decision is reported and that the patient is followed by an oncologist.",{"count":446,"type":21},100,[24],"The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction. The safety of the acellular matriz will be evaluated by estimating known and unexpected adverse event rates assessed by clinical evaluations and patient reports of adverse events after implantation in addition to monitoring integration by Magnetic Resonance Imaging (MRI). The performance of Silimed® brand acellular matriz will be evaluated by clinical effectiveness of the acellular matrix in supporting breast reconstruction, reflected by the structural and functional maintenance of the reconstructed tissue without the occurrence of major complications related to integration failure during the follow-up period. Secondary performance outcomes include: assessment of body image-related quality of life, self-esteem assessment, aesthetic and functional breast assessment, and participant satisfaction level.",[28],[451,452,453,125,454],"post-market","safety","performance","acellular matrix","2026-03-18",{"date":457,"type":35},"2026-03-20",{"date":34,"type":21},{"date":460,"type":21},"2029-06-30",{"name":462,"class":76},"Silimed Industria de Implantes Ltda",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":476,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":4},"100619131","b4p-trial---bloom43-for-preconditioning-100619131","NCT07340632","B4P Trial - BLOOM43 for Preconditioning","BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study","Inclusion Criteria:\n\n* All females over the age of 18 years (no maximum age limit)\n* Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and\u002For implant)\n\nExclusion Criteria:\n\n* Delayed (two-stage) breast reconstruction patients\n* Patients undergoing simple mastectomy or wide local excision of a breast tumour\n* Inflammatory breast cancer patients\n* Patients with ulcerated breast tumours\n* Patents with T4 breast cancer\n* Presence of open breast skin wounds, or infected or inflamed breast skin\n* Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device",{"count":86,"type":21},[24],"The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. This study aims to understand a participant's experience of the device, including its usability and acceptability.\n\nParticipants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and\u002For implant-based reconstruction).",[474,28,475],"Skin Necrosis","Breast Surgery",[477,199,478,479,480],"Mastectomy skin flap necrosis","Breast surgery","Preconditioning","Skin necrosis","2026-03-17",{"date":483,"type":35},"2026-03-19",{"date":485,"type":21},"2026-04-16",{"date":487,"type":21},"2026-12-31",{"name":489,"class":76},"Plexaa Ltd",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":496,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":109},"100609044","impact-of-pectoral-versus-paravertebral-blocks-on-pain-and-physical-well-being-in-implant-based-breast-reconstruction-100609044","NCT07209436","Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction","Inclusion Criteria:\n\n* Adult patient 18 years or older\n* Scheduled for unilateral or bilateral immediate implant-based breast reconstruction\n* Therapeutic or prophylactic indication\n* Patient understands the study procedures and objectives and is willing to participate\n* Patient willing to and capable of providing informed consent\n\nExclusion Criteria:\n\n* Delayed breast reconstruction\n* Allergy or contraindication to local anesthetics (PVB or PECS blocks)\n* History of radiation therapy\n* Planned sedation or general anesthesia protocol variation\n* Morbid obesity as defined as a BMI greater than 40 kg\u002Fm2\n* Renal insufficiency\n* Chronic pain syndrome or central sensitization disorders (e.g., fibromyalgia, CRPS)\n* Use of implanted pain devices or neuromodulators\n* Pre-existing neurological deficits in the surgical field\n* Current chronic opioid use (daily use within the 2 weeks before surgery and duration of use greater than 4 weeks)\n* Use of any nerve medications in the past 6 months, including antiepileptic medications (gabapentin, carbamazepine)\n* History of drug or alcohol abuse or habitual alcohol intake greater than two standard drinks per day (e.g., two beers, two glasses of wine, or two mixed drinks)\n* Any comorbidity that results in moderate or severe functional limitation, inability to communicate with the investigators or hospital staff\n* History of a psychiatric disorder which would interfere with the study procedure\n* Incarceration\n* Any issue that at the discretion of the investigator would contraindicate the subject's participation\n* Inability to understand the procedures and objectives of the study\n* Inability to or unwilling to provide informed consent","ALL",{"count":498,"type":21},212,[24],"The broad aim of this study is to compare the effectiveness of paravertebral and pectoral blocks on pain and physical well-being of patients undergoing immediate implant-based breast reconstruction.",[28],[28,503],"Breast cancer","2026-01-20",{"date":506,"type":35},"2026-01-22",{"date":508,"type":35},"2025-11-19",{"date":510,"type":21},"2028-06",{"name":512,"class":42},"Amy Colwell",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":496,"minAge":398,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":4},"100616901","the-effect-of-intraoperative-binaural-beats-on-remimazolam-dose-required-for-maintenance-of-general-anesthesia-100616901","NCT07311642","The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia","The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia: a Randomized, Placebo-controlled Trial","Inclusion Criteria:\n\n* Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.\n\nExclusion Criteria:\n\n* Patients with hearing impairment, hearing loss, or those using hearing aids\n* Patients with external auditory canal disease that prevents wearing earphones\n* Patients with chronic use of hypnotics or sedatives\n* Patients with a history of obstructive sleep apnea or a BMI ≥ 35 kg\u002Fm²\n* Patients with alcohol dependence or substance abuse\n* Patients deemed inappropriate for study participation at the discretion of the investigator",{"count":521,"type":21},88,[24],"This prospective randomized controlled trial evaluates whether intraoperative binaural beats reduce the remimazolam dose required for general anesthesia in 88 adults undergoing breast surgery. Patients are assigned to binaural beats or silent earphones, and the primary outcome is total intraoperative remimazolam consumption.",[28],"2025-12-30",{"date":527,"type":35},"2025-12-31",{"date":529,"type":21},"2026-01-31",{"date":531,"type":21},"2026-12-01",{"name":533,"class":42},"Seoul National University Hospital",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":109},"100618448","the-outcomes-of-fat-grafting-combined-with-latissimus-dorsi-muscle-flap-for-delayed-breast-reconstruction-after-mastectomy-100618448","NCT07331753","The Outcomes of Fat Grafting Combined With Latissimus Dorsi Muscle Flap for Delayed Breast Reconstruction After Mastectomy","Inclusion Criteria:\n\n* female patient indicated for skin sparying mastectomy\n\nExclusion Criteria:\n\n* female patients with stage 4 breast cancer",{"count":541,"type":21},20,[24],"The outcomes of fat grafting combined with latissimus dorsi muscle flap for delayed breast reconstruction after mastectomy",[29,28],"2025-12-29",{"date":547,"type":35},"2026-01-12",{"date":549,"type":35},"2025-11-01",{"date":551,"type":21},"2027-11-01",{"name":553,"class":42},"Sohag University",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":259,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":118},"100518242","melodi-matrix-in-breast-reconstruction-100518242","NCT06027996","Melodi Matrix™ in Breast Reconstruction","Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)","Inclusion Criteria:\n\n* Female.\n* Age 22 or older at the time of enrollment.\n* Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.\n* Is able to and willing to comply with the study requirements and providing informed consent.\n\nExclusion Criteria:\n\n* Has prior history of neoadjuvant radiotherapy.\n* Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.\n* Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.\n* Has a Body Mass Index (BMI) \\\u003C 14 or \\> 40.\n* Is pregnant or is nursing; or plans to become pregnant during the course of the study.\n* Has any connective tissue\u002Fautoimmune disorder or rheumatoid disease.\n* Has known allergies to study device materials.\n* Is participating in another interventional research study that may interfere with study endpoints.\n* Has limited life expectancy or co-morbid conditions, social\u002Fpsychological problems, or cognitive impairments that precludes participation.\n* Has a medical condition or is taking medications that would result in elevated risk and\u002For affect the validity of the study.\n* Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.",{"count":562,"type":21},702,[24],"Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.",[28],"2025-12-05",{"date":568,"type":35},"2025-12-08",{"date":570,"type":35},"2024-08-09",{"date":510,"type":21},{"name":573,"class":76},"Melodi Health, Inc.",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":109},"100596371","save-trial-safe-opioid-use-video-education-100596371","NCT07044583","SAVE Trial: SAfe Opioid Use Video Education","SAVE","Inclusion Criteria:\n\n* Female patients 18 years of age or older\n* Patients undergoing abdominally based autologous free flap breast reconstruction after mastectomy for breast cancer or cancer prophylaxis\n\nExclusion Criteria:\n\n* Patients undergoing reoperations such as autologous breast reconstruction as a revision procedure following failed implant-based reconstruction\n* Patients undergoing multiple procedures such as mastectomy and immediate reconstruction\n* Patients with documented chronic opioid use prior to procedure, chronic pain condition",{"count":582,"type":21},68,[24],"The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. This trial is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care).\n\nThis will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.",[28,29],"2025-11-20",{"date":588,"type":35},"2025-11-26",{"date":590,"type":35},"2025-10-27",{"date":341,"type":21},{"name":593,"class":42},"University of Utah",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":611,"leadSponsor":613,"locationsCount":4},"100611113","evaluation-of-well-being-and-patient-reported-outcomes-after-robotic-single-port-nipple-sparing-mastectomy-and-implant-reconstruction-100611113","NCT07236359","Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction","A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction","Reborn-i","Inclusion Criteria:\n\n* Women aged 18 years and older\n* Candidates who have already been selected to undergo nipple sparing mastectomy and immediate implant reconstruction by the breast MDT for the following indications:\n* Genetic mutation carriers undergoing risk-reducing mastectomy.\n* Ductal carcinoma in situ (DCIS) requiring mastectomy.\n* Early invasive breast cancer requiring mastectomy.\n* The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).\n* Candidates for immediate breast reconstruction with IMPLANT reconstruction\n* Fluent in English\n* Fit for general anaesthetic\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Advanced breast cancer with skin involvement.\n* Nipple involvement for Nipple Sparing Mastectomy Arms.\n* Prior chest wall radiation therapy\n* Pregnancy\n* Lactation\n* Patients with insufficient English to sign an informed consent (i.e. interpreter required).",{"count":603,"type":21},108,[24],"This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast.\n\nHowever, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries.\n\nThis study will compare:\n\n* Robotic nipple-sparing mastectomy\n* Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients.\n\nTaking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.",[28,29,607,288],"Hereditary Breast\u002FOvarian Cancer (brca1, brca2)","2025-11-14",{"date":508,"type":35},{"date":527,"type":21},{"date":612,"type":21},"2028-12-31",{"name":297,"class":42}]