NCT05336526进行中（未招募）不适用
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 12
- 主要终点
- Safety : Incidence of implant and/or procedure-related adverse events/complications
研究概览
简要总结
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction.
An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 65 years
- •Eligible for bilateral breast augmentation in primary intention
- •general breast enlargement for cosmetic purposes
- •surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries*, Poland's syndrome*, ptosis ... * correction of asymmetries and Poland's Syndrome with concomitant augmentation of the second breast (bilateral implantation)
- •Signature of Patient Information Consent (PIC) & willingness to comply with the protocol assessments and follow up visits
- •Affiliation to the social security regime
排除标准
- •Local or systemic infection or abscess anywhere in the body
- •Existing carcinoma or pre-carcinoma of the breast with or without treatment
- •History of subcutaneous mastectomy
- •Subject with previous tissue expansion
- •Diagnosis of active cancer of any type
- •Pregnant subject or intending to become pregnant within three (3) months after the implant procedure (women of childbearing potential must use effective contraception from 1 month before the implantation procedure until 3 months after the implantation procedure)
- •Has breastfed within three (3) months the implant surgery, or is still breastfeeding
- •Tissue characteristics determined as clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, known wound healing complications)
- •Has been previously implanted with a silicone implant or history of failure following cosmetic augmentation
- •History of autoimmune disease such as, but not limited to, lupus and scleroderma
- •Any condition or treatment for any condition which, in the opinion of the investigator, may constitute an unwarranted surgical risk (e.g. severe lung or cardiac disease, unstable medical conditions, anaesthesia allergy, heavy smokers...)
- •Anatomic or physiologic abnormality which could result to significant post-operative complications
- •History of sensitivity to foreign materials or known allergy to any component of the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implant
- •Known alcohol abuse or history of alcohol abuse
- •Psychological instability
- •Underlying disease (HIV-positive, heart failure, renal insufficiency, diabetes, hypertension)
- •Implanted metal or metal devices, history of claustrophobia, or other condition that would make a magnetic resonance imaging (MRI) scan prohibitive
- •Unwilling to undergo any further surgery for revision
- •Unrealistic/unreasonable expectations that entail a risk for the surgical procedure
- •Participating in another clinical study or within exclusion period of a previous clinical study as determined by the investigator
- •Has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study
结局指标
主要结局
Safety : Incidence of implant and/or procedure-related adverse events/complications
时间窗: 3 months post-procedure
Safety endpoint will be assessed by the incidence of implant and/or procedure-related adverse events/complications at 3 months post implant
次要结局
- Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration(at the implant procedure)
- Performance, Implant procedure Success: Surgeon comfort evaluation with size incision(at the implant procedure)
- Performance : satisfaction with the implant size choice(3 months, 1 year and 2 years post-procedure)
- Performance : global satisfaction of the surgeon(3 months, 1 year and 2 years post-procedure)
- Safety : Incidence of all AEs/SAEs(2 years post-procedure)
- Performance :Surgeon comfort evaluation with comfort level for insertion/implantation of the prothesis(Discharge Visit, an average of 24h)
- Performance : change in chest circumference at the level of the breasts(3 months, 1 year and 2 years post-procedure)
- Performance, Implant procedure Success: Assessment of implant placement and deformation(3 months post-procedure)
- Performance : global satisfaction of the patient(3 months, 1 year and 2 years post-procedure)
- Performance : number of steps of increase in bra cup size(3 months, 1 year and 2 years post-procedure)
研究者
研究点 (12)
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