first-in-human, study of mattisse® tissue engineering chamber in adult female patients undergoing breast reconstruction after mastectomy for cancer

Conditions: Breast Cancer Female; Breast Cancer Prevent; Breast Reconstruction

Summary: 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.


Eligibility criteria:
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