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.
Brief Title
AI ENRICH - AI Detection of ICH
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Intracerebral Hemorrhage
Eligibility Criteria
Inclusion Criteria:
* Subjects with stroke symptoms who undergo CT brain imaging.
Exclusion Criteria:
* Subjects with poor or incomplete CT brain imaging.
* Subjects with stroke symptoms who undergo CT brain imaging.
Exclusion Criteria:
* Subjects with poor or incomplete CT brain imaging.
Inclusion Criteria
Inclusion Criteria:
* Subjects with stroke symptoms who undergo CT brain imaging.
* Subjects with stroke symptoms who undergo CT brain imaging.
Gender
All
Gender Based
false
Keywords
Artificial Intelligence
ICH
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03865979
Org Class
Industry
Org Full Name
Viz.ai, Inc.
Org Study Id
VIZ-ICH-01
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
Primary Outcomes
Outcome Description
Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.
Outcome Measure
Performance
Outcome Time Frame
Enrollment
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498