NCT02225080已完成不适用
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Patient's Outcome
研究概览
简要总结
The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
排除标准
- •Patient who does not agree to allow collection of his/her medical data
结局指标
主要结局
Patient's Outcome
时间窗: Day 30
Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
次要结局
- Occurence of Adverse Event(Between days 15-30)
研究者
研究点 (5)
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