[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474659":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":19,"enrollmentInfo":86,"targetDuration":19,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Quanta Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MATTISSE TEC","EXPERIMENTAL","Patient included receive MATTISSE TEC",[13],"Device: MATTISSE TEC",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Tissue engineering chamber MATTISSE",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Pierre GUERRESCHI, Pr","CONTACT","03.20.44.56.59","clinic@lattice-medical.com",[27,43,56],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":31,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"CHU de Strasbourg","RECRUITING","Strasbourg","France","67091","FR",{"type":35,"coordinates":36},"Point",[37,38],7.74553,48.58392,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":19,"phoneExt":19,"email":19},"Frédéric BODIN, Pr",{"facility":44,"status":29,"city":45,"state":46,"zip":47,"country":31,"countryCode":33,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Hospital of Lille","Lille","Nord","59000",{"type":35,"coordinates":49},[50,51],3.05512,50.63391,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":19,"phoneExt":19,"email":19},"Pierre Guerreschi, Prof.",{"facility":57,"status":29,"city":58,"state":19,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Institute of Clinical Oncology","Tbilisi","0159","Georgia","GE",{"type":35,"coordinates":63},[64,65],44.83412,41.69143,{"lat":65,"lon":64},[68],{"name":69,"role":23,"phone":19,"phoneExt":19,"email":19},"Gia NEMSADZE, Pr",{"type":71,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[73],{"name":74,"class":75},"Lattice Medical","UNKNOWN","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":87,"type":88},50,"ESTIMATED","INTERVENTIONAL",[91],"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.",[94,95,96],"Breast Cancer Female","Breast Cancer Prevent","Breast Reconstruction","2025-03-18",{"date":99,"type":100},"2025-03-20","ACTUAL",{"date":102,"type":100},"2022-07-01",{"date":104,"type":88},"2028-12-31",{"name":5,"class":6},3]