NCT05062733招募中不适用
Prospective Observational Study About SEBBIN Gluteal Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Complication rate
研究概览
简要总结
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is a man or a woman ≥ 18 years old at the time of inclusion.
- •The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision
- •The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.
排除标准
- •Patient implanted with silicone implants somewhere else in the body.
- •Patient candidate for implantation with custom-designed implants.
- •Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
结局指标
主要结局
Complication rate
时间窗: At 10 years of follow-up
次要结局
未报告次要终点
研究者
研究点 (2)
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