[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632653":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":62,"collaborators":30,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":30,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":30,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":30,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"3 Preconditioning Cycles","EXPERIMENTAL","three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.",[13],"Other: 3 Cycles Thermal Preconditioning",{"label":15,"type":10,"description":16,"interventionNames":17},"1 Preconditioning Cycle","one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.",[18],"Other: 1 Cycle Thermal Preconditioning",{"label":20,"type":21,"description":22,"interventionNames":23},"Retrospective Group","ACTIVE_COMPARATOR","retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions",[24],"Other: No Intervention",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"1 Cycle Thermal Preconditioning","Thermal preconditioning with Plexaa BLOOM43 starting as close to 1 hour before the surgery as possible. Participants will keep the device on the breast for a total of 1 hour, allowing completion of one heating-cooling cycle before removing and turning off the device.",[15],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"3 Cycles Thermal Preconditioning","Thermal preconditioning with Plexaa BLOOM43 as close to 12 hours before the scheduled operation as possible. Participants will use the device as programmed, keeping it on the breast for a total of 3 hours.",[9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"No Intervention","participants did not receive intervention",[20],[40],{"name":41,"affiliation":5,"role":42},"Adam Katz, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Caleb Suggs","CONTACT","3367134339","caleb.suggs@advocatehealth.org",[50],{"facility":5,"status":30,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":30},"Winston-Salem","North Carolina","27157","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-80.24422,36.09986,{"lat":60,"lon":59},{"type":63,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100632653","thermal-preconditioning-in-mastectomy-patients-with-immediate-breast-reduction-100632653",false,"NCT07516483","Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction","Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.\n\nExclusion Criteria:\n\n* Patients with no plan for any breast reconstruction.\n* Patients with inflammatory breast cancer.\n* History of any radiation to the breast or chest wall.\n* Patients with pre-existing local dermatological conditions.\n* Patients belonging to vulnerable populations (e.g., children, pregnant individuals, incarcerated persons).\n* Patients unable to provide informed consent or comply with study procedures.","ALL","18 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy and breast reconstruction.",[81],"Breast Reconstruction After Mastectomy",[83,84,85],"heat preconditioning","mastectomy","breast reconstruction","NOT_YET_RECRUITING","2026-05-22",{"date":89,"type":90},"2026-05-26","ACTUAL",{"date":92,"type":75},"2026-07",{"date":94,"type":75},"2027-05",{"name":5,"class":6},1]