NCT04502745终止不适用
A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Incidence of all serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 55 years of age or greater.
- •Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation.
排除标准
- •Failure to obtain consent.
- •Vulnerable study population.
- •Any need for chronic anticoagulation.
- •Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma.
- •Glasgow Coma Scale (GCS) less than 8.
结局指标
主要结局
Incidence of all serious adverse events
时间窗: 3 years
Number of adverse events including unanticipated adverse device effects
次要结局
未报告次要终点
研究者
Jamie J. Van Gompel
Principal Investigator
Mayo Clinic
研究点 (2)
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