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NCT03865979 Clinical Trial

AI ENRICH - AI Detection of ICH

Intracerebral Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03865979
Other study ID # VIZ-ICH-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 23, 2020
Est. completion date December 2022

Study information
Verified date April 2022
Source Viz.ai, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5000
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with stroke symptoms who undergo CT brain imaging. Exclusion Criteria: - Subjects with poor or incomplete CT brain imaging.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Viz RECRUIT
Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York
United States SUNY Buffalo Buffalo New York
United States Cooper University Hospital Camden New Jersey
United States Geisinger Medical Center Danville Pennsylvania
United States Northshore University Health System Evanston Illinois
United States UAMS Medical Center Little Rock Arkansas

Sponsors (2)
Lead Sponsor Collaborator
Viz.ai, Inc. Nico Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performance Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH. Enrollment
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