Monitoring the Use of Collagen Dura Membrane in the Post-market Phase
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Measurement of the occurrence of adverse event requiring surgical intervention
研究概览
简要总结
Monitoring the Use of Collagen Dura Membrane in the Post-market phase
详细描述
A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix & DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with a dural defect requiring repair with a dural substitute.
排除标准
- •There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.
结局指标
主要结局
Measurement of the occurrence of adverse event requiring surgical intervention
时间窗: 6-9 months
次要结局
- Adverse events i.e., infection, CSF leak and Pseudomeningocele(6-9 months)