[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Plexaa Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100619131","b4p-trial---bloom43-for-preconditioning-100619131",false,"NCT07340632","B4P Trial - BLOOM43 for Preconditioning","BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study","Inclusion Criteria:\n\n* All females over the age of 18 years (no maximum age limit)\n* Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and\u002For implant)\n\nExclusion Criteria:\n\n* Delayed (two-stage) breast reconstruction patients\n* Patients undergoing simple mastectomy or wide local excision of a breast tumour\n* Inflammatory breast cancer patients\n* Patients with ulcerated breast tumours\n* Patents with T4 breast cancer\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},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. 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 breast the evening before undergoing surgery (mastectomy with immediate autologous and\u002For implant-based reconstruction).",[26,27,28],"Skin Necrosis","Breast Reconstruction","Breast Surgery",[30,31,32,33,34],"Mastectomy skin flap necrosis","Breast reconstruction","Breast surgery","Preconditioning","Skin necrosis","NOT_YET_RECRUITING","2026-03-17",{"date":38,"type":39},"2026-03-19","ACTUAL",{"date":41,"type":20},"2026-04-16",{"date":43,"type":20},"2026-12-31",{"name":45,"class":46},"Plexaa Ltd","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100554689","plexaa-for-preconditioning-gender-affirming-mastectomy-100554689","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",{"count":56,"type":20},15,[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).",[60,61],"Nipple Necrosis","Nipple Graft Loss",[63,64,33],"Nipple necrosis","Nipple graft loss","RECRUITING","2025-09-25",{"date":68,"type":39},"2025-10-01",{"date":70,"type":39},"2025-08-20",{"date":72,"type":20},"2026-06-01",{"name":45,"class":46},1,""]