跳至主要内容
临床试验/NCT03865979
NCT03865979Unknown不适用

Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial

Viz.ai, Inc.12 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年1月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
Viz.ai, Inc.
入组人数
5,000
试验地点
12
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

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.

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

研究者

发起方
Viz.ai, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (12)

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