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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction

Intervention / Treatment
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* Device: MATTISSE TEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria related to pathology: Female patient 18 Years to 70 Years Immediate unilateral reconstruction after mastectomy for early breast cancer or Immediate Preventive unilateral reconstruction If patients with cancer: Patient with early cancer (carcinoma in situ without lymph node metastasis) with oncological management that does not required radiotherapy after surgery Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion 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. Exclusion Criteria: Disease related criteria: Previous breast surgery Patient undergoing delayed or bilateral reconstructions Patient undergoing bilateral preventive mastectomy Patients undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation Previous history of radiotherapy 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 patients (HIV) or patients used immunosuppressants Medical device related criteria Allergy to any of the components of the medical device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MATTISSE TEC<br>Patient included receive MATTISSE TEC | Device: MATTISSE TEC<br>* Tissue engineering chamber MATTISSE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 associated to MATTISSE® TEC: Skin necrosis that requires only debridement Flap necrosis Subcutaneous hematoma: any hematoma requiring surgical exploration Infection 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 associated to MATTISSE® TEC: Necrosis of skin or flap Infection Prothesis exposure/ Implant malposition Device failure or defect: when the prothesis breaks or collaps | 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 | 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of tissue expansion (flap enlargement) from implantation up to 12 months post operation. | Tissue expansion will be assessed using MRI at discharge (after surgery), 3, 6 and 12 months post operative. All MRI imaging will be assessed by and independent expert radiologist. | Surgery visit, 3, 6, and 12 months post-intervention (24 months post intervention for 10 first patient) | 
| Evolution of breast softness from inclusion to 12 months | The breast softness will be assessed by investigator surgeon and patients themselves at discharge (after surgery), 3, 6 and 12 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 | Surgery visit, 3, 6, and 12 months post-intervention (24 months post intervention for 10 first patient) | 
| Evolution of MATTISSE® TEC resorption until 12 months follow up: the resorption is active between 6 and 12 months after surgery. At 12 months the resorption of MATTISSE® TEC is not complete. | MATTISSE® TEC resorption will be observed quantitatively on MRI achieved at 3, 6 and 12 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 | Surgery visit, 3, 6, and 12 months post-intervention (24 months post intervention for 10 first patient) | 
| The volume of the reconstructed breast compared to the volume of the contralateral one at 12 months | At 12 months, we will assess during physical examinations, the volume of the reconstructed breast and the volume of the contralateral one. | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| Aesthetic breast appearance before and after surgery using photo | Aesthetic breast appearance will be assessed before surgery, 6 and 12-months post-surgery using standardized photographs. The assessment will be done by the surgeon and 2 independent external specialists who validated standardized photographs. The following scoring points will be used: Excellent: Treated breast nearly identical to that before surgery Good: Treated breast slightly different to that before surgery Fair: Treated breast clearly different to that before surgery but not seriously distorted Poor: Treated breast seriously distorted compared to that before surgery | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| The maintain of breast (i.e., flap) volume stability at 12 months compared to that at 6 months | Flap volume at 12 months is compared at that assessed at 6 months using MRI. All MRI imaging will be assessed by and independent expert radiologist. | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| The impact of the flap transfer on the donor site assessed at surgery, 3-, 6- and 12-months post-surgery | Impact of the flap transfer on the donor site will be assessed at surgery, 3-, 6- and 12-months post-surgery using different parameters: Tissue necrosis (Yes/ No) Symmetry of the donor site area (comparing to the other side of the patient): Yes/ No | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| Pain (VAS) | Pain score will be assessed at inclusion, discharge, M3, M6 and M12 using a 10 Visual Analogue Scale [VAS, 0 (no pain) and 10 (worst possible pain)] | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| The quality of life and the satisfaction of patients | Quality of life and patients' satisfaction will be done through the BREAST-Q© questionnaire (module of reconstruction pre and post-surgery version) at inclusion and at 3, 6 and 12 months post operative. The quality of life is evaluated through 2 scales (psychological well-being and physical well-being: breast). The satisfaction is evaluated with 1 scale : (satisfaction with breast). | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure. | - Surgeons' satisfaction regarding the use of MATTISSE® TEC and implantation procedure will be assessed on: Global satisfaction of the surgeon (5 points Likert scale) Ease of use Material ergonomics Ease of insertion Ease of fixing Safety up to 12 months, will be assessed by measuring the complication rate in implant-based immediate breast reconstruction using MATTISSE® TEC. Adverse events up to 12 months post operation will be recorded. | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery | 
| Safety up to 24 months post operation | Minor complications associated to MATTISSE® TEC Skin necrosis that requires only debridement Flap necrosis Subcutaneous hematoma: any hematoma requiring surgical exploration Infection 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 associated to MATTISSE® TEC: Necrosis of skin or flap Infection Prothesis exposure/ Implant malposition Device failure or defect: when the prothesis breaks or collaps | 3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery |