NCT02678156已完成不适用
Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Incidence of re-operation because of Cerebrospinal Fluid leakage
研究概览
简要总结
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
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 undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
- •Written informed consent
- •Life expectancy > 6 months
- •Age > 18 years
排除标准
- •Active local or systemic infections
- •Open cranial trauma
- •Open spina bifida
- •Known hypersensitivity to proteins of bovine origin
- •Representation by a legal guardian or under involuntary commitment
- •Pregnancy
- •Participation in another clinical study
- •Known primary immunodeficiency
结局指标
主要结局
Incidence of re-operation because of Cerebrospinal Fluid leakage
时间窗: until discharge (approximately 1 week)
次要结局
- Incidence of re-operation because of Cerebrospinal Fluid leakage(until follow-up (4 ± 2 months))
- Incidence of post operative complications(until discharge (approximately 1 week, 4±2 months))
- Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage(until discharge (approximately 1 week, 4±2 months))
- Intraoperative handling of the device(Intraoperative)
研究者
研究点 (3)
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