[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Musculoskeletal Transplant Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":20,"type":21},259,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique",[27],"Implant Based Breast Reconstruction","RECRUITING","2025-03-27",{"date":31,"type":32},"2025-04-02","ACTUAL",{"date":34,"type":32},"2025-03-26",{"date":36,"type":21},"2027-08",{"name":38,"class":39},"Musculoskeletal Transplant Foundation","OTHER",""]