NCT04923867已完成不适用
A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 3
- 主要终点
- Patient Outcome
研究概览
简要总结
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
详细描述
This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18 and 80 years of age
- •Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
- •Availability of post-operative assessment results.
排除标准
- •There are no exclusionary criteria for this study population
结局指标
主要结局
Patient Outcome
时间窗: post-up to 90 days
Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure
次要结局
- Occurrence of Adverse Event(Between days 30-90)
研究者
研究点 (3)
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