NCT03516136已完成不适用
A Retrospective Study for Collecting Data on the Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
Allium, Ltd.0 个研究点目标入组 84 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- Safety- procedure and device related complication rate
研究概览
简要总结
A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Female subjects >18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP
排除标准
- •Patients without follow-up
结局指标
主要结局
Safety- procedure and device related complication rate
时间窗: Up to 4 years
Percentage of device and procedure related complications.
次要结局
未报告次要终点
研究者
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