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

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About this study

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.

Condition
Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
Tested
MATTISSE TEC
Sponsor
Quanta Medical

Who can join

Age
18 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 47

  • Minimum age: 18 years
  • Eligible sex: Female
  • Study condition: Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
  • 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 3

  • 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

Where

3 sites, 3 recruiting

Hospital of Lille

Lille, Nord, France

Recruiting

CHU de Strasbourg

Strasbourg, France, France

Recruiting

Institute of Clinical Oncology

Tbilisi, Georgia

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.