First-in-human Study of MATTISSE® Tissue Engineering Chamber in Adult Female After Total Mastectomy for Breast Cancer in Immediate or Delayed 2-stage Tissue Expander Reconstruction or Conversion from Implant-based to Autologous Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.
时间窗: 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.
时间窗: 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
次要结局
- The quality of life and the satisfaction of patients(3, 6, 12, 24 and 36 months post surgery)
- Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure.(Visit 2, surgery)
- 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)
- Pain (VAS)(3, 6, 12, 24 and 36 months post surgery)
- Evolution of breast softness from inclusion to 36 months(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.(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(3, 6, 12, 24 and 36 months post surgery)
- Aesthetic breast appearance before and after surgery using photo(3, 6, 12, 24 and 36 months post 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)
- 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)
- Safety up to 36 months post operation(Surgery visit, 3, 6, 12, 24 and 36 months post-intervention)
- Evolution of biological parameters up to 6 months after surgery(Inclusion, Discharge, 3, 6 months post-intervention)