NCT04057157已完成不适用
Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage
研究概览
简要总结
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Planned use of the Biodesign Dural or Duraplasty Graft.
排除标准
- •Age <18 years
- •Unable or unwilling to provide informed consent
- •Life expectancy <6 months
结局指标
主要结局
Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage
时间窗: 2 months
Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).
次要结局
未报告次要终点
研究者
研究点 (3)
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