Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Local complications
研究概览
简要总结
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
详细描述
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction at 3 months, 1 year and 2 years post-procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient will be included if all of the following criteria are met:
- •Subject of between 18 and 65 years old
- •Candidate eligible for :
- •a. unilateral or bilateral breast augmentation i. general breast enlargement: cosmetic purposes, providing symmetry to opposite breast in case of unilateral surgery ii. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries, Poland's syndrome, ptosis ...
- •b. or immediate or delayed unilateral or bilateral breast reconstruction (for cancer, trauma, surgical loss of breast)
- •Patient signs PIC (Patient Informed Consent) & willing to comply with the protocol assessments and visits follow up
排除标准
- •Patient will not be included if any of the following conditions exists:
- •Local or systemic infection or abscess anywhere in the body
- •Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion
- •Subject with previous tissue expansion
- •Diagnosis of active cancer of any type for augmentation procedure subject
- •Pregnant subject or intending to become pregnant within three (3) months of the implant procedure
- •Subject who had nursed within three (3) months of implant surgery, or still breastfeeding
- •Tissue characteristics determined clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, know complication wound healing)
- •Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy
- •History of autoimmune disease such as but not limited to: lupus, scleroderma ...
- •Any condition or treatment for any condition which, in the opinion of the physician, may constitute an unwarranted surgical risk (e.g. anaesthesia allergy, high consumption smoking subject ...)
- •Anatomic or physiologic abnormality which could result to significant post-operative complications
- •History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant
- •Subject known for alcohol abuse/history
- •Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, ...)
- •Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive
- •Unwilling to undergo any further surgery for revision
- •Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure
- •Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion
- •Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study
结局指标
主要结局
Local complications
时间窗: 3 months
Evaluation of the safety 3 months post-implantation. Procedure-related adverse events/complications at 3 months post implant. Main foreseen complications: infection, haematoma, wound healing complication, fluid accumulation, early capsular contracture, rupture, extrusion.
Satisfaction of the patient and the surgeon
时间窗: 3 months
Evaluation of the performance, 3 months post-implantation Performance endpoint will be assessed by implant procedure success at 3 months defined as follows: * satisfactory procedure duration for the surgeon * satisfactory size of the incision for the surgeon * implant correct placement (absence of visible deformation of the gel, absence of rotation for anatomical implants)
次要结局
- Local complications(1 year and 2 years)
- Satisfaction of the patient and the surgeon(1 year and 2 years)