NCT04733638Unknown不适用
Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Viz.ai, Inc.
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Algorithm Performance
研究概览
简要总结
To evaluate the performance of the Viz ICH VOLUME algorithm.
详细描述
To evaluate the performance of the Viz ICH VOLUME algorithm to:
- detect the presence of ICH on brain imaging,
- measure the volume of ICH on brain imaging,
- and to assess the algorithm processing time,
- and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Adult patients (18 and older)
- •Presenting with symptoms suspicious for an acute stroke / intracranial hemorrhage
- •Having a complete imaging data set including NCCT +/- MRI, CTA and/or MRA
排除标准
- •Subjects with poor or incomplete brain imaging.
结局指标
主要结局
Algorithm Performance
时间窗: Up to 10 minutes
Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.
次要结局
- Algorithm Processing Time(Up to 10 minutes)
- Time to Notification(Up to 10 minutes)
- Time to Treatment(up to 1 day (1440 minutes))
- Length of Stay(Hospital admit to discharge, up to 30 days)
- In Hospital Complications(Hospital admit to discharge, up to 30 days)
- Modified Rankin Scale (mRS) at Discharge and 90 Days(90 days)
研究者
研究点 (5)
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