NCT04494295招募中不适用
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 31
- 主要终点
- Rate of Surgical Success
研究概览
简要总结
This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject Age is > 18
- •Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume > 20 mL, assessed via standard of care techniques
- •Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms.
- •Subject has a NIHSS score > 5
- •Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2
- •Subject with a CT Angiography demonstrating no vascular malformation
排除标准
- •Subject has an underlying vascular lesion defined as causative source of ICH
- •Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing
- •Subject has an Infratentorial or brainstem ICH
- •Subject has a known life expectancy < 6 months
- •Subject has an uncorrectable coagulopathy
- •Subject has a mechanical heart valve
- •Subject is pregnant
- •Subject participates in another concurrent interventional clinical trial
- •Subject who is unable to meet study follow-up requirements
研究组 & 干预措施
AURORA
Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma
干预措施: Aurora Surgiscope System (Device)
结局指标
主要结局
Rate of Surgical Success
时间窗: During surgical procedure to evacuate supratentorial intracerebral hemorrhage
Rate of surgical success defined as reduction to \< 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan
次要结局
未报告次要终点
研究者
研究点 (31)
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