[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577358":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":20,"locations":25,"responsibleParty":45,"collaborators":47,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":28,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Musculoskeletal Transplant Foundation","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","FlexHD® Pliable",[13,14],"Device: FlexHD® Pliable","Other: No intervention",[16,21],{"type":17,"name":11,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Acellular Dermal Matrix",[9],null,{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"No intervention","Historical Control Arm",[9],[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Jonathan Heistein, MD Plastic & Reconstructive Surgery","RECRUITING","Fort Worth","Texas","76092","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-97.32085,32.72541,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":20,"email":20},"Office","CONTACT","(817) 820-0000",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[48,51],{"name":49,"class":50},"MCRA (an IQVIA business)","UNKNOWN",{"name":52,"class":50},"Bruder Consulting International, LLC","100577358","flexhd-pliable-investigation-in-implant-based-breast-reconstruction-100577358",false,"NCT06797258","FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction","Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction","SHAPE","Inclusion Criteria:\n\n* Females at least 22 years of age\n* Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction\n* Willing to provide Informed Consent\n* Able to return for all required study visits\n* Must read and understand English language\n\nExclusion Criteria:\n\n* Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure\n* Has a residual gross tumor at the intended reconstruction site\n* Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy\n* Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site\n* Completed chemotherapy within 3 weeks prior to surgery\n* Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications\n* Has a Body Mass Index (BMI) \\>35\n* Has used nicotine products within 1 month of screening\n* Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study","FEMALE","22 Years",{"count":64,"type":65},259,"ESTIMATED","INTERVENTIONAL",[68],"NA","Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique",[71],"Implant Based Breast Reconstruction","2025-03-27",{"date":74,"type":75},"2025-04-02","ACTUAL",{"date":77,"type":75},"2025-03-26",{"date":79,"type":65},"2027-08",{"name":5,"class":6},1]