[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nipple-necrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nipple-necrosis":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100554689",false,"NCT06502353","Plexaa For Preconditioning: Gender Affirming Mastectomy","A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study","P4PGAM","Inclusion Criteria:\n\n* All transgender or non-binary patients over the age of 18 years (no maximum age limit)\n* Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation\n\nExclusion Criteria:\n\n* Patients undergoing surgery for breast cancer\n* Delayed (two-stage) breast reconstruction patients\n* Patients undergoing simple mastectomy or wide local excision of a breast tumour\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","FEMALE","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. 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 right breast the evening before undergoing surgery (gender affirming mastectomy).",[26,27],"Nipple Necrosis","Nipple Graft Loss",[29,30,31],"Nipple necrosis","Nipple graft loss","Preconditioning","RECRUITING","2025-09-25",{"date":35,"type":36},"2025-10-01","ACTUAL",{"date":38,"type":36},"2025-08-20",{"date":40,"type":20},"2026-06-01",{"name":42,"class":43},"Plexaa Ltd","INDUSTRY",""]