[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619131":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":30,"collaborators":32,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":20,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":20,"enrollmentInfo":48,"targetDuration":20,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":20},{"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 ipsilateral breast (the breast to be operated on) and the preconditioning protocol will be undertaken 12 hours before surgery - i.e. the evening before. Patients will then attend hospital for their breast surgery the next day as planned. For the patients undergoing bilateral skin\u002Fnipple-sparing mastectomy with immediate reconstruction, they will be asked to precondition only the right breast.",[13],"Device: BLOOM43",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","BLOOM43","BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Saahil Mehta","CONTACT","447711183551","saahil@plexaa.com",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":29},"Hadyn Kankam","hadyn@plexaa.com",{"type":31,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[33,36],{"name":34,"class":35},"Royal Marsden NHS Foundation Trust","OTHER",{"name":37,"class":38},"Portsmouth Hospitals NHS Trust","OTHER_GOV","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":49,"type":50},60,"ESTIMATED","INTERVENTIONAL",[53],"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).",[56,57,58],"Skin Necrosis","Breast Reconstruction","Breast Surgery",[60,61,62,63,64],"Mastectomy skin flap necrosis","Breast reconstruction","Breast surgery","Preconditioning","Skin necrosis","NOT_YET_RECRUITING","2026-03-17",{"date":68,"type":69},"2026-03-19","ACTUAL",{"date":71,"type":50},"2026-04-16",{"date":73,"type":50},"2026-12-31",{"name":5,"class":6}]