[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-prevent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-prevent":28},{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100474659","first-in-human-study-of-mattisse-tissue-engineering-chamber-in-adult-female-patients-undergoing-breast-reconstruction-after-mastectomy-for-cancer-100474659",false,"NCT05460780","First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer","First-in-human Study of MATTISSE® Tissue Engineering Chamber in Adult Female After Total Mastectomy for Breast Cancer in Immediate or Delayed 2-stage Tissue Expander Reconstruction or Conversion From Implant-based to Autologous Reconstruction","TIDE","Inclusion Criteria:\n\nCriteria related to pathology:\n\n* Female patient over 18 Years old\n* Patient who required autologous breast reconstruction:\n\n  * Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer\n  * Breast reconstruction after unilateral preventive total mastectomy\n  * or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation\n  * or conversion from implant-based to autologous reconstruction: Patient who had a breast implant during a previous reconstruction after total mastectomy for cancer, and who needs to change it.\n* For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \\\u003C 50mm, without lymph-node involvement) needing oncological management that does not required radiotherapy after surgery on the breast area or on the flap donor site\n* Patient who required Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion; or implant removal for patient undergoing autologous conversion, or expender removal for patient undergoing differed reconstruction.\n* Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.\n* Patient medically fit for surgery without significant comorbidities\n* Breast cup-size less than D\n* Body mass index \\>20 kg\u002Fm2 or patient for whom sufficient flap volume is expected according to surgeon's assessment\n* Adequate hematopoietic functions\n\nCriteria related to population:\n\n* Subjects who have given free, informed and written consent to participate in the study;\n* Patient able to answer questionnaires, able to communicate in the language of the study country;\n* Subjects affiliated to a social security schema or entitled to a social security scheme.\n\nNon-inclusion Criteria:\n\nPathology related criteria:\n\n* Patient undergoing bilateral reconstruction\n* Patient undergoing bilateral preventive mastectomy\n* Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation\n* Previous history of radiotherapy on the breast area or on the flap donor site\n* Previous history of breast or axillary surgery that does not allow fat flap dissection\n* Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI\n* Body mass index \\>30 kg\u002Fm2\n* Taking medication for weight loss at the time of inclusion visit\n* Presence of major medical conditions that may compromise patient's health and healing\n* Diabetes and a history of gestational diabetes\n* Active smoking\n* Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)\n* Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination\n* Allergy to anesthetics or contrast media\n* Immunocompromised patient (HIV) or patient used immunosuppressants\n\nPopulation related criteria\n\n* Pregnant patient\n* or breastfeeding patient or woman who has nursed a child three months within inclusion\n* Participation in a clinical trial in the 3 months prior to the initial visit\n* Predicted unavailability during study.\n* Patient deprived of liberty or under guardianship.\n* Patient unable to give consent\n\nMedical device related criteria\n\n* Allergy to any of the components of the medical device.\n\nEXCLUSION CRITERIA\n\n* Positive or suspicious extemporaneous sentinel node biopsy\n* Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler\n* Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment","FEMALE","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a first in human, two-stage single arm non-comparative study of safety and performance.\n\nThe aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.",[27,28,29],"Breast Cancer Female","Breast Cancer Prevent","Breast Reconstruction","RECRUITING","2025-03-18",{"date":33,"type":34},"2025-03-20","ACTUAL",{"date":36,"type":34},"2022-07-01",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"Quanta Medical","INDUSTRY",3]