[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lipofilling\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lipofilling":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100641341","evaluation-of-the-efficacy-and-safety-of-using-platelet-rich-fibrin-prf-based-lipobolus-for-the-immediate-reconstruction-of-defects-after-breast-conserving-resection-for-breast-cancer-minimally-invasive-primary-immediate-grafting-100641341",false,"NCT07658170","Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)","MINIPIG","Inclusion Criteria:\n\n* Histologically verified breast cancer (BC).\n* Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition).\n* Tumor grade G1 or G2.\n* Estrogen receptor positivity (ER+).\n* ECOG performance status = 0.\n* Primary tumor size up to 2 cm, based solely on preoperative examination data (mammography, ultrasound, MRI).\n* Indications for breast-conserving surgery (BCS) with a breast resection extent determined by a multidisciplinary oncology board.\n* Submission of an informed voluntary consent (IVC) regarding participation in the study.\n* Ability to understand and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n* Male gender.\n* ECOG ≥ 1.\n* Multifocal or multicentric tumor.\n* Grade G3.\n* Triple-negative or HER2-positive tumor with uncontrolled disease.\n* Stage cT3 or higher or distant metastases (M1).\n* Inflammatory breast cancer.\n* Prior neoadjuvant chemotherapy or hormonal therapy.\n* Prior radiation therapy to the breast.\n* Presence of blood coagulation disorders (coagulopathy, thrombocytopathy, thrombocytopenia \\\u003C 100 × 10⁹\u002FL).\n* Taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued.\n* Presence of active infectious diseases.\n* Acute autoimmune diseases.\n* Decompensated comorbidities (diabetes mellitus, cardiovascular diseases, etc.).\n* Body mass index (BMI) \\\u003C 18.5 kg\u002Fm² (insufficient adipose tissue volume for liposuction).\n* Pregnancy or lactation.\n* Mental illnesses that prevent informed consent.\n* Known allergy to local anesthetics or sodium citrate.","FEMALE","18 Years","69 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if a special type of fat graft, made by mixing a person's own fat with platelet-rich fibrin (PRF), works to fix breast shape defects after cancer surgery. PRF is a substance made from a person's own blood that is rich in growth factors, which may help the graft survive better.\n\nThe main questions it aims to answer are:\n\nWhat percentage of the fat graft's volume remains in place 3 months after radiation therapy?\n\nWhat is the safety of this procedure, including its side effects and any impact on cancer returning?\n\nParticipants will:\n\n* Undergo standard breast-conserving surgery to remove the tumor\n* Have liposuction (fat removal) from their own belly or thighs\n* Receive a \"lipobolus\" (their own fat mixed with PRF) placed into the breast defect during the same surgery\n* Follow up for 12 months with ultrasound scans, physical exams, and questionnaires (BREASTQ) about their satisfaction and quality of life",[27,28,29,30],"Breast Cancer","Lipofilling","Fat Graft","Platelet Rich Plasma","RECRUITING","2026-06-14",{"date":34,"type":35},"2026-06-18","ACTUAL",{"date":37,"type":35},"2025-11-13",{"date":39,"type":21},"2028-06-03",{"name":41,"class":42},"The Leningrad Regional Clinical Hospital","OTHER_GOV",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"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":53,"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",[27,57,58,59,28],"Breast Reconstruction","Breast Reconstruction After Mastectomy","Breast Cancer Radiation",[28,61,62],"Breast reconstruction","Irradiated patients","NOT_YET_RECRUITING","2026-06-09",{"date":66,"type":35},"2026-06-11",{"date":68,"type":21},"2026-07-01",{"date":70,"type":21},"2032-07-01",{"name":72,"class":73},"Maastricht University Medical Center","OTHER",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"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":82,"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.",[57,28,86],"Hyperbaric Oxygen Therapy",[88,89,90,91],"breast reconstruction","Irradiation","hyperbaric oxygen therapy","lipofilling","2026-05-11",{"date":94,"type":35},"2026-05-14",{"date":96,"type":35},"2026-03-01",{"date":98,"type":21},"2028-12",{"name":100,"class":73},"University Hospital, Geneva"]