Monitoring the Use of Collagen Dura Membrane - Suturable (DMS) 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
- 54
- 试验地点
- 1
- 主要终点
- Rate of Adverse Events Requiring Surgical Intervention
研究概览
简要总结
Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase
详细描述
A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation.
No original patient records or patient identifying information will be disclosed to Collagen Matrix.
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
- •Patient is 18 years or older
- •Patient of child-bearing potential is not pregnant or nursing
排除标准
- •Patients with a known history of hypersensitivity to bovine derived materials
- •Patients that are non-English speaking
- •Subjects requiring Legally Authorized Representative
结局指标
主要结局
Rate of Adverse Events Requiring Surgical Intervention
时间窗: 9 months
Rate of adverse events related to subject device and requiring surgical intervention.
次要结局
- Rate of Adverse Events(9 months)
- Score of adequacy of product performance(9 months)
- Score for Product Handling at Implantation(9 months)
- Score for Product Adaptability at Implantation(9 months)