NCT02905617终止不适用
Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Investigator Overall Satisfaction Questionnaire
研究概览
简要总结
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
详细描述
This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Is a candidate for primary or revision breast augmentation and is at least 22 years of age,
- •Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.
排除标准
- •Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery
- •Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.
结局指标
主要结局
Investigator Overall Satisfaction Questionnaire
时间窗: 12 months
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
次要结局
未报告次要终点
研究者
研究点 (1)
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