Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
Conditions
Brief summary
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.
Interventions
DEVICEMATTISSE TEC
Tissue engineering chamber MATTISSE
Sponsors
Lattice Medical
Quanta Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded. | 6 months post-surgery | 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. |
| 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. | 6 months post-surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of MATTISSE® TEC resorption until 36 months follow up: the resorption is active between 6 and 12 months after surgery. | Surgery visit, 3, 6, 12, 24 and 36 months post-intervention | 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 |
| The volume of the reconstructed breast compared to the volume of the contralateral one at 12, 24 and 36 months | 3, 6, 12, 24 and 36 months post surgery | 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. |
| Aesthetic breast appearance before and after surgery using photo | 3, 6, 12, 24 and 36 months post surgery | Aesthetic breast appearance will be assessed before surgery, 6 at 12, 24 and 36 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 |
| The maintain of breast (i.e., flap) volume stability at 12, 24 and 36 months compared to that at 6 months | 3, 6, 12, 24 and 36 months post surgery | Flap volume at 12, 24 and 36 months is compared at that assessed at 6 months using MRI. All MRI imaging will be assessed by and independent expert radiologist. |
| The impact of the flap transfer on the donor site assessed at surgery, 3, 6, 12, 24 and 36months post-surgery | 3, 6, 12, 24 and 36 months post surgery | Impact of the flap transfer on the donor site will be assessed at surgery, 3, 6, 12, 24 and 36 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 |
| Evolution of tissue expansion (flap enlargement) from implantation up to 36 months post operation. | Surgery visit, 3, 6, 12, 24 and 36 months post-intervention | 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. |
| The quality of life and the satisfaction of patients | 3, 6, 12, 24 and 36 months post surgery | 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). |
| Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure. | Visit 2, surgery | \- 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 |
| Evolution of biological parameters up to 6 months after surgery | Inclusion, Discharge, 3, 6 months post-intervention | Complete blood counts evolution will be assessed at inclusion, at discharge, and at 3 and 6 months post-implantation, by measuring Hemoglobin , leukocytes Lymphocyte rate Neutrophil rate and Thrombocytes Units: * Hemoglobin : g/L * leukocytes :10⁹/L * Lymphocyte rate : % * Neutrophil rate : % * Thrombocytes : 10⁹/L |
| Safety up to 36 months post operation | Surgery visit, 3, 6, 12, 24 and 36 months post-intervention | Safety up to 36 months, will be assessed by measuring the complication rate after breast reconstruction using MATTISSE® TEC. Adverse events up to 36 months post operation will be recorded. |
| Pain (VAS) | 3, 6, 12, 24 and 36 months post surgery | Pain score will be assessed at inclusion, discharge, 3, 6, 12, 24 and 36 month using a 10 Visual Analogue Scale \[VAS, 0 (no pain) and 10 (worst possible pain)\] |
| Evolution of breast softness from inclusion to 36 months | Surgery visit, 3, 6, 12, 24 and 36 months post-intervention | * 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 |
Countries
France, Georgia
Contacts
Primary ContactPierre GUERRESCHI, Pr
Outcome results
None listed