AI ENRICH - AI Detection of ICH
Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
1 other identifier
interventional
10
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedSeptember 19, 2024
September 1, 2024
3.1 years
March 4, 2019
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance
Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.
Enrollment
Study Arms (2)
Intervention Arm
ACTIVE COMPARATORSubject 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
Control Arm
NO INTERVENTIONSubjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation
Interventions
Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB
Eligibility Criteria
You may qualify if:
- Subjects with stroke symptoms who undergo CT brain imaging.
You may not qualify if:
- Subjects with poor or incomplete CT brain imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viz.ai, Inc.lead
- Nico Corporationcollaborator
Study Sites (6)
UAMS Medical Center
Little Rock, Arkansas, 72205, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
SUNY Buffalo
Buffalo, New York, 14203, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian T Jankowitz, MD
The Cooper Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 7, 2019
Study Start
January 23, 2020
Primary Completion
March 15, 2023
Study Completion
April 28, 2023
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share