[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-reconstruction-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-reconstruction-surgery":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100517128","post-market-prospective-clinical-study-of-nagor-perle-mammary-implants-100517128",false,"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","FEMALE","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","OBSERVATIONAL","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",[26,27,28,29,30,31,32,33],"Breast Reconstruction","Breast Reconstruction Following Mastectomy","Breast Revision","Breast Augmentation","Breast Reconstruction With Silicone Implants","Breast Reconstruction After Mastectomy","Breast Reconstruction Surgery","Breast Implants",[35,36,37,38,39,40,41,42],"prospective","observational","non-comparative","post-marketing study","PMCF","Perle","Nagor","GCA","RECRUITING","2026-06-25",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":47},"2024-06-01",{"date":51,"type":22},"2038-09",{"name":53,"class":54},"GCA (Eurosilicone)","INDUSTRY",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100558863","tissue-reinforcement-for-breast-reconstruction-trbr-pivotal-clinical-study-redefine-100558863","NCT06556654","Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)","Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction","Inclusion Criteria:\n\n1. Female subjects ≥ 22 years of age.\n2. First-time breast reconstruction post-mastectomy for target breast(s).\n3. Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.\n4. Mastectomy performed to address breast cancer or for cancer prophylaxis.\n5. An informed consent form is signed by Subject or Legally Authorized Representative (LAR).\n6. Subject is capable of following protocol procedures and complying with follow-up visit requirements\n\nExclusion Criteria:\n\nBaseline Exclusion Criteria\n\n1. Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction.\n2. Subject has undergone previous radiation therapy to the reconstruction site or chest wall.\n3. Subject has had chemotherapy within 3 weeks prior to the index procedure.\n4. Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.\n5. Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).\n6. Subject has a BMI \\> 35.\n7. Subject has a known diagnosis of diabetes with a HbA1c \\> 7.0mmol\u002FL within 30 days of the Index procedure (i.e., TE placement).\n8. Subject was a current or former tobacco\u002Fnicotine user, within 90 days prior to Index Surgery (i.e., TE placement).\n9. Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.\n10. Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.\n11. Subject is currently participating in or planning to participate in another investigational drug, biologic or medical device study that may interfere with compliance of TBR 22-07 study requirements or may confound TBR 22-07 study data\u002Foutcomes.\n12. Subject requires a surgical technique requiring flap (autologous tissue).\n13. Subject is pregnant or lactating at the time of the index procedure (i.e., TE placement) or is planning to become pregnant prior to the Exchange procedure. Intraoperative Index Procedure Exclusion\n14. Based on investigator's opinion, subject has unsuitable tissue integrity for immediate 2-stage breast reconstruction or is no longer a candidate to receive the TRBR Device (will be recorded as a screen failure).\n15. Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)","22 Years",{"count":65,"type":22},180,"INTERVENTIONAL",[68],"NA","The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Control Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Control Arm.",[32],[72,73,74,75,76,77,78,79],"breast reconstruction","post-mastectomy","tissue expander","implant based breast reconstruction","two-stage","immediate","subpectoral","prepectoral","2025-10-21",{"date":82,"type":47},"2025-10-23",{"date":84,"type":47},"2025-04-09",{"date":86,"type":22},"2030-07",{"name":88,"class":54},"W.L.Gore & Associates",20,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":100,"studyType":23,"phases":4,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":55},"100572073","partial-breast-reconstruction-with-chest-wall-perforator-flap-100572073","NCT06728527","PARTial BREast RECONstruction With Chest Wall Perforator Flap","PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes","PartBreCon","Inclusion Criteria:\n\n* Patients undergoing partial breast reconstruction using CWPF for primary breast cancer\n* Delayed correction of breast deformity following previous BCS\n* Each surgeon is to have performed a minimum of 10 CWPFs\n* Each centre anticipates completing a minimum of 10\u002Fyear\n\nExclusion Criteria:\n\n* Patients undergoing volume displacement BCS\n* Patients undergoing mastectomy +\u002F- immediate breast reconstruction",{"count":99,"type":22},1001,"6 Months","The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.",[103,104,105,106,32],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Carcinoma","Breast Neoplasms","Breast Surgery",[108],"breast oncoplastic, recon, chest wall perforator flap, PROMS","2024-12-07",{"date":111,"type":47},"2024-12-11",{"date":113,"type":47},"2023-06-01",{"date":115,"type":22},"2026-05-31",{"name":117,"class":118},"Cambridge University Hospitals NHS Foundation Trust","OTHER"]