[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626362":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":32,"responsibleParty":43,"collaborators":32,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":32,"enrollmentInfo":55,"targetDuration":32,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":32},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Motiva Flora® tissue expander","EXPERIMENTAL","Within the first operation (OP 1, visit 1), patients will receive an expander (=inflatable silicone implant) to increase the amount of tissue available for breast reconstruction. The expander is positioned in the subcutaneous plane combined with or without a GalaFLEX™ matrix, a biologically derived 2D scaffold, with native tissue ingrowth through its poly-4-hydroxybutyrate (P4HB)-based open-pore monofilament structure, providing immediate supplemental soft tissue repair support and long-term strength. Matrix\u002FScaffold are only needed for fixation of Mentor expanders, not for Motiva Flora expander. The Motiva Flora® Tissue Expanders also includes two fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket.",[13],"Radiation: intervention (unilateral\u002Fbilateral), scheduled for (NSME\u002FSSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Mentor® SILTEX™ BECKER™","In case of MENTOR™ SILTEX™ BECKER™ expanders, the MENTOR™ TRUE-LOCK™ Connector is designed to join the preinserted or preattached fill tube of the Mentor expander to the injection dome. Once the MENTOR™ SILTEX™ BECKER™ expanders are expanded to the desired volume, the fill tube and injection dome will not be removed through a small incision under local anesthetic, instead the fill tube and injection dome are kept in situ, until the expander is replaced with the definitive implant. Therefore no additional operation is needed and the risk for infections will be reduced.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Collective I: subjects with adjuvant radiotherapy -","The decision regarding the adjuvant radiotherapy following breast implantation is be made by the surgeon and the radiation oncologist before inclusion into the study. Radiotherapy planning and dose constraints will be based on CT stimulation and will be scheduled according to therapeutic guidelines. The radiotherapy will be conducted routinely for three weeks (every week: 5 days with 2 days break). Pre-radiotherapy clinical examination (visit 5) and post-radiotherapy clinical examination (visit 6) is planned after the expander inflation 2.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Collective II: subjects without adjuvant radiotherapy","Patients, who will not receive adjuvant radiotherapy, will not attend to visit \"pre-radiotherapy clinical examination\" and visit \"post-radiotherapy clinical examination\". For this collective II, visit 5 will be the preparation for final breast reconstruction (OP 2). But if there is a need for adjuvant radiotherapy based on interdisciplinary tumor board desicion (at Visit 1, Visit 2 or Visit 3), Subject will change from Collectove 2 to Collective 1",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"RADIATION","intervention (unilateral\u002Fbilateral), scheduled for (NSME\u002FSSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy","Patients who are scheduled for tissue expander-based breast reconstruction will be randomized in one of two expander groups (Arm 1= Motiva Flora® Tissue Expander \\& Arm 2 = SILTEX™ BECKER™ expander). Subjects, who are routinely scheduled for radiotherapy (collective I) will subsequently undergo two additional visits. Subjects without scheduled radiotherapy (collective II), will continue without additional visits - unless they need to change their collective for therapeutic reasons.\n\nAssesments:\n\n1. efficacy and safety of therapeutic and prophylactic comparative tissue expander-based breast reconstruction\n2. structural and functional changes in comparative tissue expanders following exposure to radiotherapy vs. non-radiotherapy",[9,15,19,23],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Assoc. Prof. PD. Dr. Dolores Wolfram-Raunicher, MBA Department","CONTACT","43\u002F512\u002F504\u002F82050","dolores.wolfram@i-med.ac.at",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},"Assoc. Prof. PD. Dr. med. univ. Barbara Del-Frari Department o","43\u002F512\u002F504\u002F80899","barbara.del-frari@tirol-kliniken.at",{"type":44,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":56,"type":57},80,"ESTIMATED","INTERVENTIONAL",[60],"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).",[63,64,65,66],"Mastectomy and Breast Reconstruction","Tissue Expander Based Breast Reconstruction","Adjuvant Radiotherapy","Long Term Outcome",[68,69,70],"breast reconstruction","implant capsular fibrosis","tissue expander comparison","NOT_YET_RECRUITING","2026-02-20",{"date":74,"type":75},"2026-02-25","ACTUAL",{"date":77,"type":57},"2026-03-01",{"date":79,"type":57},"2031-12-31",{"name":5,"class":6}]