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

Quanta Medical

Status: Enrolling

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

Treatments: Device: MATTISSE TEC

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05460780

3121_MATFIH22

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

MATTISSE TEC

Experimental group

Description:

Patient included receive MATTISSE TEC

Treatment:

Device: MATTISSE TEC