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

Quanta Medical50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer Female Breast Cancer Prevent Breast Reconstruction

Interventions

MATTISSE TECDEVICE

Tissue engineering chamber MATTISSE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

CHU de Strasbourg

Strasbourg, France, France

RECRUITING

Hospital of Lille

Lille, Nord, France

RECRUITING

Institute of Clinical Oncology

Tbilisi, Georgia

RECRUITING

Outcomes

Primary Outcomes

Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.

Minor complications include: * Superficial skin necrosis that requires only debridement * Flap necrosis * Subcutaneous hematoma: any hematoma requiring surgical exploration * Inflammatory reaction * Seroma: defined as that which requires echo-guided puncture at least once after drain removal. * Pain * Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention * Implant malposition * Superficial Venous Thrombosis (Mondor disease) * Capsular contracture Major complications include: * All complications that lead to MATTISSE® TEC removal: * Skin necrosis leading to implant exposure * Infection * Implant malposition leading to implant exposure * Device failure or defect: when the implant breaks or collapses, e.g., the base separates from the shell, failure at the time of surgical placement (fracture of the TEC before placement) * Granuloma.

Time frame: 6 months post-surgery

Performance objective: To assess the efficacy at 6 months post-operation of breast reconstruction using MATTISSE® breast implants in patients undergoing breast reconstitution after total mastectomy surgery for cancer.

Success is defined as: * Tissue expansion (flap enlargement) from implantation up to 6 months post operation --\> A 50% increase in the expanded size at 6 months compared to initial size flap is considered as a success. Indeed, the optimal growth of the flap is expected at 6 months, * Tissue expansion will be assessed using MRI at discharge (after surgery) and 6 months post operative. The volume of flap at 6 months will be compared to the flap size initially implanted. All MRI imaging will be assessed by and independent expert radiologist. Failure is defined as: * less than 50% increase in the expanded size at 6 months compared to initial size flap MATTISSE® Prothesis removal

Time frame: 6 months post-surgery

Secondary Outcomes

Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation.

Tissue expansion will be assessed using MRI at discharge (after surgery), 12, 24 and 36 months post operative. All MRI imaging will be assessed by and independent expert radiologist.

Central Contacts

Pierre GUERRESCHI, Pr

CONTACT

03.20.44.56.59 clinic@lattice-medical.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention

Evolution of breast softness from inclusion to 36 months

* The breast softness will be assessed by investigator surgeon and patients themselves at discharge (after surgery), 3, 6 ,12, 24 and 36 months as: * Stage 1: Breast is soft * Stage 2: Breast is hard * Stage 3: Breast is hard with distortion * Stage 4: Breast is hard, painful with distortion

Time frame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention

Evolution of MATTISSE® TEC resorption until 36 months follow up: the resorption is active between 6 and 12 months after surgery.

MATTISSE® TEC resorption will be observed quantitatively on MRI achieved at 3, 6, 12, 24 and 36 months associated with the touch of the surgeon and patients feeling. The TEC resorption will be classified as: * Absent: no resorption at all. * Small resorption: TEC has been reabsorbed a little bit compared to the initial * Great resorption: TEC has been absorbed a lot but not totally * Total: Shell and base are no longer visible on the MRI and not felt by the surgeon

Time frame: Surgery visit, 3, 6, 12, 24 and 36 months post-intervention

The volume of the reconstructed breast compared to the volume of the contralateral one at 12, 24 and 36 months

At 12, 24 and 36 months, we will assess during physical examinations, the volume of the reconstructed breast and the volume of the contralateral one.