NCT05987475招募中不适用
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Rate of capsular contracture
研究概览
简要总结
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years old and above, and under 60 years old;
- •has approved and signed the informed consent form;
- •eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
- •Willing to be followed up for a period of 10 years.
排除标准
- •Informed pregnancy or breastfeeding at the time of inclusion
- •Known hypersensitivity and / or allergy to silicone;
- •Not understanding or not accepting the risks of further surgeries during follow-up;
- •Body mass index > 40 kg/m²;
- •HbA1c levels > 7,5%;
- •History of repeated failure with the implantation of similar implants;
- •Tissue or fat insufficiency;
- •Progressive breast cancer large tumours (>5 cm), late cancer stage and deep tumours;
- •Grossly positive axillary involvement / or chest wall involvement;
- •High risk of cancer recurrence;
- •Tissue damage in the implant area due to irradiation of the thoracic wall;
- •Pre-existing pathology in the implant area;
- •General infection or infection in the implant area;
- •Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications;
- •History or presence of an autoimmune disease;
- •Immunocompromised;
- •History or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin/tissue / microwave diathermy / or steroids;
- •Medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent;
- •Concomitantly part of another interventional clinical trial.
- •Under supervision or legal guardianship
- •Deprived of liberty by a judicial or administrative decision
- •Not affiliated to health insurance system or is a beneficiary of such coverage
结局指标
主要结局
Rate of capsular contracture
时间窗: From implantation to end of study (10-year)
To describe the rate of capsular contracture. Capsular contracture will be evaluated according to the Baker classification (from I to IV with grade III/IV considered as retractile capsular contractures).
Post-surgery rupture
时间窗: From implantation to end of study (10-year)
To describe the rate of post-surgery rupture. Rupture will be evaluated based on cases of hardening or deflation, based on clinical signs and if deemed necessary by the investigator, by medical imaging (mammography, ultrasound, MRI).
次要结局
- Breast implant survival rate.(From implantation to end of study (10-year))
- Participant's QoL(From implantation to end of study (10-year))
- Frequency of occurrence of other adverse events and complications(From implantation to end of study (10-year))
- Participant's and investigator's satisfaction regarding the aesthetic result(From implantation to end of study (10-year))
- Reoperation rate(From implantation to end of study (10-year))
研究者
研究点 (1)
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