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First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer

RecruitingNAAges 18 Years - anyFemaleQuanta Medical
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In plain words

What the trial is, and whether it could suit you

This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Criteria related to pathology: * Female patient over 18 Years old * Patient who required autologous breast reconstruction: * Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer * Breast reconstruction after unilateral preventive total mastectomy * or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation * 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. * For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \< 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 * 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. * 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. * Patient medically fit for surgery without significant comorbidities * Breast cup-size less than D * Body mass index \>20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment * Adequate hematopoietic functions Criteria related to population: * Subjects who have given free, informed and written consent to participate in the study; * Patient able to answer questionnaires, able to communicate in the language of the study country; * Subjects affiliated to a social security schema or entitled to a social security scheme. Non-inclusion Criteria: Pathology related criteria: * Patient undergoing bilateral reconstruction * Patient undergoing bilateral preventive mastectomy * Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation * Previous history of radiotherapy on the breast area or on the flap donor site * Previous history of breast or axillary surgery that does not allow fat flap dissection * Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI * Body mass index \>30 kg/m2 * Taking medication for weight loss at the time of inclusion visit * Presence of major medical conditions that may compromise patient's health and healing * Diabetes and a history of gestational diabetes * Active smoking * Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease) * Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination * Allergy to anesthetics or contrast media * Immunocompromised patient (HIV) or patient used immunosuppressants Population related criteria * Pregnant patient * or breastfeeding patient or woman who has nursed a child three months within inclusion * Participation in a clinical trial in the 3 months prior to the initial visit * Predicted unavailability during study. * Patient deprived of liberty or under guardianship. * Patient unable to give consent Medical device related criteria * Allergy to any of the components of the medical device. EXCLUSION CRITERIA * Positive or suspicious extemporaneous sentinel node biopsy * Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler * Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment
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What it tests

  • MATTISSE TEC
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Where

3 sites
CHU de Strasbourg
Strasbourg, France
Hospital of Lille
Lille, France
Institute of Clinical Oncology
Tbilisi, Georgia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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