NCT07214623尚未招募不适用
i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Effectiveness
研究概览
简要总结
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.
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
- •Pre morbid mRS 0-3
- •Chronic subdural symptomatic, requiring intervention
排除标准
- •Acute subdural hematoma
- •Intercranial mass other than subdural hematoma
- •Females pregnant or breast feeding
- •Compromised survival or inability to complete trial
结局指标
主要结局
Effectiveness
时间窗: 6 months
Incidence of hematoma recurrence or progression requiring repeat embolization within 180 days
Safety
时间窗: 90 days
Modified rankin scale at 90 days post procedure
次要结局
未报告次要终点
研究者
研究点 (2)
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