AI ENRICH - AI Detection of ICH

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Device: Viz RECRUIT

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 Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • UAMS Medical Center
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Health System
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14203
      • SUNY Buffalo
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with stroke symptoms who undergo CT brain imaging.

Exclusion Criteria:

• Subjects with poor or incomplete CT brain imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Viz RECRUIT; Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB
No Intervention: Control Arm; Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.	Enrollment

Collaborators and Investigators

• Sponsor: Viz.ai, Inc.
• Collaborators: Nico Corporation
• Investigators: Principal Investigator: Brian T Jankowitz, MD, The Cooper Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ICH; Artificial Intelligence
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: VIZ-ICH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No