[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nipple-sparing-mastectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nipple-sparing-mastectomy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100521762","the-role-of-amnion-membrane-allografts-in-nipple-preservation-100521762",false,"NCT06073808","The Role of Amnion Membrane Allografts in Nipple Preservation","The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial","AmnioFix","Inclusion Criteria:\n\n* Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.\n* Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.\n\nExclusion Criteria:\n\n* Current steroid use\n* Known connective tissue disorder\n* Known neuropathy\n* Known history of breast cancer\n* History of breast radiotherapy\n* Pregnant or nursing",true,"ALL","15 Years","75 Years",{"count":22,"type":23},30,"ESTIMATED","INTERVENTIONAL",[26],"NA","The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion\u002Fchorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.",[29,30,31,32,33],"Mastectomy","Gender Affirmation Surgery","Nipple Sparing Mastectomy","Prophylactic Mastectomy","Benign Breast Condition",[35,36],"nipple sparing mastectomy","gender affirming surgery","NOT_YET_RECRUITING","2026-04-24",{"date":40,"type":41},"2026-04-30","ACTUAL",{"date":43,"type":23},"2026-06-01",{"date":45,"type":23},"2026-09",{"name":47,"class":48},"Stanford University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100573622","endoscopic-and-robotic-nsm-with-immediate-prosthesis-breast-reconstruction-100573622","NCT06748677","Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction","Prospective Cohort Study of Minimally Invasive Surgery Versus Traditional Open Surgery for Nipple Areola Preserving Mastectomy Combined with Immediate Prosthesis Reconstruction","EnRoNSM","Inclusion Criteria:\n\n1. Underwent surgical treatment at Peking University People's Hospital, with hospitalization records;\n2. Preoperative core needle biopsy confirmed breast cancer;\n3. The clinical stage of the tumor is stage 0-IIIB; 4）cT≤5cm， cN0\u002FcN1，M0， And there is no tumor invasion of the nipple areola complex, skin, and chest wall;\n\n5\\) Intraoperative plan to use non biological patches (such as TiLoop) to partially or completely wrap the prosthesis 6) Signed agreement to participate in this study; 7) Can cooperate to complete the Patient Reported Outcome Measures (PROMs) questionnaire.\n\nExclusion Criteria:\n\n1. Lack of clinical pathological data (such as imaging data, pathological data);\n2. Pregnancy or lactation period;\n3. Patients with metastatic breast cancer or bilateral breast cancer;\n4. Have undergone breast conserving surgery\u002Fchest radiation therapy before;\n5. Patients with nipple areola invasion and subsequent removal of nipple areola complex;\n6. Failed to undergo curative surgery;","FEMALE",{"count":60,"type":23},484,"5 Years","OBSERVATIONAL","Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic\u002Frobotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results.\n\nThis project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy\u002Frobot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.",[65,66,67,68],"Nipple-sparing Mastectomy","Immediate Prosthesis Reconstruction","Endoscopic Surgery","Robotic Surgery","RECRUITING","2025-01-05",{"date":72,"type":41},"2025-01-07",{"date":74,"type":41},"2025-01-03",{"date":76,"type":23},"2031-12-31",{"name":78,"class":48},"Peking University People's Hospital"]