Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Rate of Revision Surgery
研究概览
简要总结
Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
详细描述
A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.
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
- •Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice
- •Patient is 18 years or older
- •Patient of child-bearing potential is not pregnant or nursing
- •Participant is willing and able to provide consent
排除标准
- •Patients with a known history of hypersensitivity to bovine derived materials
- •Patients that are non-English speaking
- •Patients requiring legal representation
结局指标
主要结局
Rate of Revision Surgery
时间窗: at least one timepoint at 8 months or more post-surgery
Rate of adverse events related to the Subject Device requiring surgical intervention.
次要结局
- Rate of Adverse Events(at least one timepoint at 8 months or more post-surgery)
- Product Performance(at least one timepoint at 8 months or more post-surgery)
- Product Handling at Implantation(Initial surgery)
- Product Adaptability at Implantation(Initial surgery)