[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554689":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":57,"collaborators":59,"id":62,"slug":32,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":32,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Plexaa Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All participants (single arm)","EXPERIMENTAL","Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their right breast and the preconditioning protocol will be done 12 hours before surgery - i.e. the evening before. Patients will then attend their breast surgery the next day as planned.",[13],"Device: BLOOM43",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","BLOOM43","Heat preconditioning",[9],[21],"Plexaa preconditioning device",[23],{"name":24,"affiliation":25,"role":26},"Dung Nguyen","Stanford University","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Saahil Mehta","CONTACT","447711183551",null,"saahil@plexaa.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Hadyn Kankam","447539351830","hadyn@plexaa.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Division of Plastic & Reconstructive Surgery, Stanford University","RECRUITING","Palo Alto","California","94304","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-122.14302,37.44188,{"lat":51,"lon":50},[54],{"name":24,"role":30,"phone":55,"phoneExt":32,"email":56},"650-498-6004","nguyendh@stanford.edu",{"type":58,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[60],{"name":25,"class":61},"OTHER","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":72,"type":73},15,"ESTIMATED","INTERVENTIONAL",[76],"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).",[79,80],"Nipple Necrosis","Nipple Graft Loss",[82,83,84],"Nipple necrosis","Nipple graft loss","Preconditioning","2025-09-25",{"date":87,"type":88},"2025-10-01","ACTUAL",{"date":90,"type":88},"2025-08-20",{"date":92,"type":73},"2026-06-01",{"name":5,"class":6},1]