NCT00905645已完成不适用
Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,788
- 试验地点
- 2
- 主要终点
- Local Complications
研究概览
简要总结
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Local Complications
时间窗: 10 Years
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
次要结局
- Satisfaction Determined by Patients(10 Years)
研究者
研究点 (2)
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