Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Viz.ai, Inc.
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Performance
研究概览
简要总结
To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.
详细描述
This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Subjects with stroke symptoms who undergo CT brain imaging.
排除标准
- •Subjects with poor or incomplete CT brain imaging.
研究组 & 干预措施
Intervention Arm
Subject CT images assessed by Viz RECRUIT software in "real time" analysis All subjects in which the Viz RECRUIT software is utilized will be identified per cohort described below per PI confirmation of ENRICH Trial status/Study ID.
Cohort A: Subjects with imaging data Cohort B: Subjects with imaging data and ultimately enrolled as part of the ENRICH Trial
干预措施: Viz RECRUIT (Device)
Control Arm
Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation
结局指标
主要结局
Performance
时间窗: Enrollment
Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.
次要结局
未报告次要终点
