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

Recruiting now · Not applicable

Conditions studied: Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT05460780

Run by

Quanta Medical

People needed

50

Starts

2022-07-01

Expected to finish

2028-12-31

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• CHU de Strasbourg — Strasbourg, France, France (enrolling)
• Hospital of Lille — Lille, Nord, France (enrolling)
• Institute of Clinical Oncology — Tbilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

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