NCT03865979

AI ENRICH - AI Detection of ICH

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Viz.ai, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DEVICE	Viz RECRUIT	Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB

Timeline

• Start date: 2020-01-23
• Primary completion: 2023-03-15
• Completion: 2023-04-28
• First posted: 2019-03-07
• Last updated: 2024-09-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study