NCT01639053进行中（未招募）不适用
U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,498
- 试验地点
- 1
- 主要终点
- Long-term safety of Sientra Silicone Gel Breast Implants in women
研究概览
简要总结
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Genetic female with US residency
- •Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
- •Agrees to Sientra study requirements
排除标准
- •Has an active infection anywhere in body
- •Has active cancer without adequate treatment
- •Currently pregnant or nursing
- •Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
- •If control participant, has undergone breast implant surgery with silicone gel-filled breast implants
研究组 & 干预措施
Gel Participants
Control Participants
结局指标
主要结局
Long-term safety of Sientra Silicone Gel Breast Implants in women
时间窗: 10-years
次要结局
未报告次要终点
研究者
研究点 (1)
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