💬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