NCT04189172进行中（未招募）不适用
Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 328
- 试验地点
- 7
- 主要终点
- Incidence of complications
研究概览
简要总结
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
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
- •Written informed consent
- •Age > 18 years
- •Duraplasty using Neuro-Patch® according to the Instructions for Use
排除标准
- •Use in infected regions
- •Use in open cerebrocranial traumata
- •Use in open spina bifida
- •Known hypersensitivity to implant materials
- •Pregnancy
- •Representation by a legal guardian or under involuntary commitment
研究组 & 干预措施
Neuro-Patch
Patients receiving Neuro-Patch® for duraplasty
结局指标
主要结局
Incidence of complications
时间窗: until follow-up (up to one year after surgery)
Incidence of complications, with (potential) causal relationship to Neuro-Patch
次要结局
- Handling measures(Intraoperative)
- Incidence of complications not related to Neuro Patch(until follow-up (up to one year after surgery))
研究者
研究点 (7)
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