[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"long-term-outcome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:long-term-outcome":30},{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100626362","comparison-of-mastectomy-expander-trial-100626362",false,"NCT07434648","Comparison of Mastectomy Expander Trial","Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial","COMMET","Inclusion Criteria:\n\n* Understands and agrees to comply with the study procedures and provides informed consent as documented by signature\n* Female subjects aged ≥ 18 years at time of consent\n* INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND \u002F OR positive genetic counseling for high-risk family history of breast cancer\n* RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction\n* Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said or written.\n* Inclusion criterion 6 only applies to subject with radiotherapy: Adjuvant radiotherapy as part of the breast cancer treatment plan\n* Inclusion criterion 7 only applies to women of childbearing potential (WOCBP): negative urine pregnancy test, not breastfeeding\n\nExclusion Criteria:\n\n* Subject with implanted device that may be affected by magnetic fields (pacemaker)\n* Known presence of HIV, viral hepatitis (patient-reported)\n* Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy\n* The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.","FEMALE","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the \"approved\" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy\u002Fexpander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.\n\nRequested answers:\n\n* how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment,\n* how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants,\n* how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material,\n* which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).",[27,28,29,30],"Mastectomy and Breast Reconstruction","Tissue Expander Based Breast Reconstruction","Adjuvant Radiotherapy","Long Term Outcome",[32,33,34],"breast reconstruction","implant capsular fibrosis","tissue expander comparison","NOT_YET_RECRUITING","2026-02-20",{"date":38,"type":39},"2026-02-25","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2031-12-31",{"name":45,"class":46},"Medical University Innsbruck","OTHER"]