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