[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mammary-reconstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mammary-reconstruction":25},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100657694","a-clinical-study-evaluating-the-safety-and-performance-of-eurosilicone-integrated-valve-tissue-expanders-ivte-100657694",false,"NCT07842406","A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)","A Retrospective, Multi-center, Observational, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone IVTE Range of Silicone Breast Expanders When Used for Breast Reconstruction.","Inclusion Criteria:\n\n* • Subjects aged ≥18\n\n  * Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:\n\n    * Reconstruction of the breast following subcutaneous mastectomy and other mastectomy procedures or trauma.\n    * Breast underdevelopment and combined breast and chest wall abnormalities.\n    * Scar\u002Fdefect revision\n  * Subjects who have received a Eurosilicone IVTE.\n\nExclusion Criteria:\n\n* Subjects with contra-indication to the surgery or not filling Instruction for Use (IFU) indications, contra-indications.","FEMALE","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Patients can undergo breast reconstruction surgery in two stages before implantation of the permanent prosthesis for several reasons. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.\n\nThis study is designed to collect data on Integrated valve tissue expander to assess the performance and safety data on this device.",[24,25],"Breast Reconstruction","Mammary Reconstruction","NOT_YET_RECRUITING","2026-09-21",{"date":29,"type":30},"2026-09-25","ACTUAL",{"date":32,"type":20},"2026-10",{"date":34,"type":20},"2027-10",{"name":36,"class":37},"GCA (Eurosilicone)","INDUSTRY"]