[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474659":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":63,"studyPopulation":63,"armGroups":70,"interventions":77,"overallOfficials":63,"centralContacts":82,"locations":88,"responsibleParty":132,"collaborators":134,"id":138,"slug":63,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":63,"enrollmentInfo":147,"targetDuration":63,"studyType":150,"phases":151,"briefSummary":152,"conditions":153,"keywords":63,"overallStatus":91,"whyStopped":63,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Quanta Medical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":63},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.","Minor complications include:\n\n* Superficial skin necrosis that requires only debridement\n* Flap necrosis\n* Subcutaneous hematoma: any hematoma requiring surgical exploration\n* Inflammatory reaction\n* Seroma: defined as that which requires echo-guided puncture at least once after drain removal.\n* Pain\n* Delayed wound healing\u002Fwound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention\n* Implant malposition\n* Superficial Venous Thrombosis (Mondor disease)\n* Capsular contracture\n\nMajor complications include:\n\n* All complications that lead to MATTISSE® TEC removal:\n* Skin necrosis leading to implant exposure\n* Infection\n* Implant malposition leading to implant exposure\n* Device failure or defect: when the implant breaks or collapses, e.g., the base separates from the shell, failure at the time of surgical placement (fracture of the TEC before placement)\n* Granuloma.","6 months post-surgery",{"measure":14,"description":15,"timeFrame":12},"Performance objective: To assess the efficacy at 6 months post-operation of breast reconstruction using MATTISSE® breast implants in patients undergoing breast reconstitution after total mastectomy surgery for cancer.","Success is defined as:\n\n* Tissue expansion (flap enlargement) from implantation up to 6 months post operation --\\> A 50% increase in the expanded size at 6 months compared to initial size flap is considered as a success. Indeed, the optimal growth of the flap is expected at 6 months,\n* Tissue expansion will be assessed using MRI at discharge (after surgery) and 6 months post operative. The volume of flap at 6 months will be compared to the flap size initially implanted. All MRI imaging will be assessed by and independent expert radiologist.\n\nFailure is defined as:\n\n* less than 50% increase in the expanded size at 6 months compared to initial size flap MATTISSE® Prothesis removal",[17,21,24,27,31,34,37,40,43,46,50,54,56,58,60],{"measure":18,"description":19,"timeFrame":20},"Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation.","Tissue expansion will be assessed using MRI at discharge (after surgery), 12, 24 and 36 months post operative.\n\nAll MRI imaging will be assessed by and independent expert radiologist.","Surgery visit, 3, 6, 12, 24 and 36 months post-intervention",{"measure":22,"description":23,"timeFrame":20},"Evolution of breast softness from inclusion to 36 months","* The breast softness will be assessed by investigator surgeon and patients themselves at discharge (after surgery), 3, 6 ,12, 24 and 36 months as:\n* Stage 1: Breast is soft\n* Stage 2: Breast is hard\n* Stage 3: Breast is hard with distortion\n* Stage 4: Breast is hard, painful with distortion",{"measure":25,"description":26,"timeFrame":20},"Evolution of MATTISSE® TEC resorption until 36 months follow up: the resorption is active between 6 and 12 months after surgery.","MATTISSE® TEC resorption will be observed quantitatively on MRI achieved at 3, 6, 12, 24 and 36 months associated with the touch of the surgeon and patients feeling. The TEC resorption will be classified as:\n\n* Absent: no resorption at all.\n* Small resorption: TEC has been reabsorbed a little bit compared to the initial\n* Great resorption: TEC has been absorbed a lot but not totally\n* Total: Shell and base are no longer visible on the MRI and not felt by the surgeon",{"measure":28,"description":29,"timeFrame":30},"The volume of the reconstructed breast compared to the volume of the contralateral one at 12, 24 and 36 months","At 12, 24 and 36 months, we will assess during physical examinations, the volume of the reconstructed breast and the volume of the contralateral one.","3, 6, 12, 24 and 36 months post surgery",{"measure":32,"description":33,"timeFrame":30},"Aesthetic breast appearance before and after surgery using photo","Aesthetic breast appearance will be assessed before surgery, 6 at 12, 24 and 36 months post-surgery using standardized photographs. The assessment will be done by the surgeon and 2 independent external specialists who validated standardized photographs.\n\nThe following scoring points will be used:\n\n* Excellent: Treated breast nearly identical to that before surgery\n* Good: Treated breast slightly different to that before surgery\n* Fair: Treated breast clearly different to that before surgery but not seriously distorted\n* Poor: Treated breast seriously distorted compared to that before surgery",{"measure":35,"description":36,"timeFrame":30},"The maintain of breast (i.e., flap) volume stability at 12, 24 and 36 months compared to that at 6 months","Flap volume at 12, 24 and 36 months is compared at that assessed at 6 months using MRI.\n\nAll MRI imaging will be assessed by and independent expert radiologist.",{"measure":38,"description":39,"timeFrame":30},"The impact of the flap transfer on the donor site assessed at surgery, 3, 6, 12, 24 and 36months post-surgery","Impact of the flap transfer on the donor site will be assessed at surgery, 3, 6, 12, 24 and 36 months post-surgery using different parameters:\n\n* Tissue necrosis (Yes\u002F No)\n* Symmetry of the donor site area (comparing to the other side of the patient): Yes\u002F No",{"measure":41,"description":42,"timeFrame":30},"Pain (VAS)","Pain score will be assessed at inclusion, discharge, 3, 6, 12, 24 and 36 month using a 10 Visual Analogue Scale \\[VAS, 0 (no pain) and 10 (worst possible pain)\\]",{"measure":44,"description":45,"timeFrame":30},"The quality of life and the satisfaction of patients","Quality of life and patients' satisfaction will be done through the BREAST-Q© questionnaire (module of reconstruction pre and post-surgery version) at inclusion and at 3, 6 and 12 months post operative. The quality of life is evaluated through 2 scales (psychological well-being and physical well-being: breast).\n\nThe satisfaction is evaluated with 1 scale : (satisfaction with breast).",{"measure":47,"description":48,"timeFrame":49},"Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure.","\\- Surgeons' satisfaction regarding the use of MATTISSE® TEC and implantation procedure will be assessed on: Global satisfaction of the surgeon (5 points Likert scale)\n\n* Ease of use\n* Material ergonomics\n* Ease of insertion\n* Ease of fixing","Visit 2, surgery",{"measure":51,"description":52,"timeFrame":53},"Evolution of biological parameters up to 6 months after surgery","Complete blood counts evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by measuring Hemoglobin , leukocytes Lymphocyte rate Neutrophil rate and Thrombocytes\n\nUnits:\n\n* Hemoglobin : g\u002FL\n* leukocytes :10⁹\u002FL\n* Lymphocyte rate : %\n* Neutrophil rate : %\n* Thrombocytes : 10⁹\u002FL","Inclusion, Discharge, 3, 6 months post-intervention",{"measure":51,"description":55,"timeFrame":53},"C-reactive protein evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by measuring CRP\n\nUnit:\n\n\\- CRP : nmoL\u002FL",{"measure":51,"description":57,"timeFrame":53},"Total protein evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by total protein assay\n\nUnit:\n\nTotal protein: Normal or Not normal",{"measure":51,"description":59,"timeFrame":53},"Protein electrophoresis will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by performing protein electrophoresis.\n\nUnit :\n\nProtein electrophoresis: Normal or Not normal",{"measure":61,"description":62,"timeFrame":20},"Safety up to 36 months post operation","Safety up to 36 months, will be assessed by measuring the complication rate after breast reconstruction using MATTISSE® TEC. Adverse events up to 36 months post operation will be recorded.",null,{"allocation":65,"interventionModel":66,"interventionModelDescription":63,"primaryPurpose":67,"observationalModel":63,"timePerspective":63,"maskingInfo":68},"NA","SINGLE_GROUP","OTHER",{"masking":69,"maskingDescription":63,"whoMasked":63},"NONE",[71],{"label":72,"type":73,"description":74,"interventionNames":75},"MATTISSE TEC","EXPERIMENTAL","Patient included receive MATTISSE TEC",[76],"Device: MATTISSE TEC",[78],{"type":79,"name":72,"description":80,"armGroupLabels":81,"otherNames":63},"DEVICE","Tissue engineering chamber MATTISSE",[72],[83],{"name":84,"role":85,"phone":86,"phoneExt":63,"email":87},"Pierre GUERRESCHI, Pr","CONTACT","03.20.44.56.59","clinic@lattice-medical.com",[89,105,118],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":93,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"CHU de Strasbourg","RECRUITING","Strasbourg","France","67091","FR",{"type":97,"coordinates":98},"Point",[99,100],7.74553,48.58392,{"lat":100,"lon":99},[103],{"name":104,"role":85,"phone":63,"phoneExt":63,"email":63},"Frédéric BODIN, Pr",{"facility":106,"status":91,"city":107,"state":108,"zip":109,"country":93,"countryCode":95,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Hospital of Lille","Lille","Nord","59000",{"type":97,"coordinates":111},[112,113],3.05512,50.63391,{"lat":113,"lon":112},[116],{"name":117,"role":85,"phone":63,"phoneExt":63,"email":63},"Pierre Guerreschi, Prof.",{"facility":119,"status":91,"city":120,"state":63,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Institute of Clinical Oncology","Tbilisi","0159","Georgia","GE",{"type":97,"coordinates":125},[126,127],44.83412,41.69143,{"lat":127,"lon":126},[130],{"name":131,"role":85,"phone":63,"phoneExt":63,"email":63},"Gia NEMSADZE, Pr",{"type":133,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR",[135],{"name":136,"class":137},"Lattice Medical","UNKNOWN","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":148,"type":149},50,"ESTIMATED","INTERVENTIONAL",[65],"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.",[154,155,156],"Breast Cancer Female","Breast Cancer Prevent","Breast Reconstruction","2025-03-18",{"date":159,"type":160},"2025-03-20","ACTUAL",{"date":162,"type":160},"2022-07-01",{"date":164,"type":149},"2028-12-31",{"name":5,"class":6},3]