[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554689":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":28,"interventions":35,"overallOfficials":43,"centralContacts":48,"locations":58,"responsibleParty":77,"collaborators":79,"id":82,"slug":21,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":21,"enrollmentInfo":91,"targetDuration":21,"studyType":94,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":61,"whyStopped":21,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Plexaa Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Participant experience","Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.","30 days",[14,18],{"measure":15,"description":16,"timeFrame":17},"Compliance","Proportion of participants who are compliant with the preconditioning protocol","1 day",{"measure":19,"description":20,"timeFrame":12},"Nipple necrosis\u002Fnipple graft loss","Proportion of participants experiencing partial or complete nipple necrosis\u002Fnipple graft loss and the rate of hospital readmission due to this",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"NA","SINGLE_GROUP","PREVENTION",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE",[29],{"label":30,"type":31,"description":32,"interventionNames":33},"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.",[34],"Device: BLOOM43",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","BLOOM43","Heat preconditioning",[30],[42],"Plexaa preconditioning device",[44],{"name":45,"affiliation":46,"role":47},"Dung Nguyen","Stanford University","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":21,"email":53},"Saahil Mehta","CONTACT","447711183551","saahil@plexaa.com",{"name":55,"role":51,"phone":56,"phoneExt":21,"email":57},"Hadyn Kankam","447539351830","hadyn@plexaa.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Division of Plastic & Reconstructive Surgery, Stanford University","RECRUITING","Palo Alto","California","94304","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-122.14302,37.44188,{"lat":71,"lon":70},[74],{"name":45,"role":51,"phone":75,"phoneExt":21,"email":76},"650-498-6004","nguyendh@stanford.edu",{"type":78,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[80],{"name":46,"class":81},"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":92,"type":93},15,"ESTIMATED","INTERVENTIONAL",[23],"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).",[98,99],"Nipple Necrosis","Nipple Graft Loss",[101,102,103],"Nipple necrosis","Nipple graft loss","Preconditioning","2025-09-25",{"date":106,"type":107},"2025-10-01","ACTUAL",{"date":109,"type":107},"2025-08-20",{"date":111,"type":93},"2026-06-01",{"name":5,"class":6},1]