AI ENRICH - AI Detection of ICH

Not Applicable

• Conditions: Intracerebral Hemorrhage
• Interventions: Device: Viz RECRUIT

• Registration Number: NCT03865979
• Lead Sponsor: Viz.ai, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Study Start: 2020-01-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Subjects with stroke symptoms who undergo CT brain imaging.

Exclusion Criteria

• Subjects with poor or incomplete CT brain imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Viz RECRUIT	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

Primary Outcome Measures

Name	Time	Method
Performance	Enrollment	Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.

Trial Locations

Locations (6)

UAMS Medical Center; 🇺🇸 Little Rock, Arkansas, United States

SUNY Buffalo; 🇺🇸 Buffalo, New York, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Northshore University Health System; 🇺🇸 Evanston, Illinois, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States