ADVANCE- Automated Detection and Volumetric Assessment of ICH

• Conditions: Intracerebral Hemorrhage
• Interventions: Device: Viz ICH VOLUME

• Registration Number: NCT04733638
• Lead Sponsor: Viz.ai, Inc.

Brief Summary

To evaluate the performance of the Viz ICH VOLUME algorithm.

Detailed Description

To evaluate the performance of the Viz ICH VOLUME algorithm to:

1. detect the presence of ICH on brain imaging,

2. measure the volume of ICH on brain imaging,

3. and to assess the algorithm processing time,

4. and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-02-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-01
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Adult patients (18 and older)
• Presenting with symptoms suspicious for an acute stroke / intracranial hemorrhage
• Having a complete imaging data set including NCCT +/- MRI, CTA and/or MRA

Exclusion Criteria

• Subjects with poor or incomplete brain imaging.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Viz ICH VOLUME	Viz ICH VOLUME	Patient data collected post-Viz ICH VOLUME implementation

Primary Outcome Measures

Name	Time	Method
Algorithm Performance	Up to 10 minutes	Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.

Secondary Outcome Measures

Name	Time	Method
Algorithm Processing Time	Up to 10 minutes	Total run time in minutes for the algorithm to process the CT scan following receipt
Time to Notification	Up to 10 minutes	Time in minutes from CT imaging to time an interventionalist was notified
Time to Treatment	up to 1 day (1440 minutes)	Time in minutes from CT imaging to start time of treatment
Length of Stay	Hospital admit to discharge, up to 30 days	Number of days in hospital
In Hospital Complications	Hospital admit to discharge, up to 30 days	Occurrence of stroke-related or stroke treatment-related complications while in hospital
Modified Rankin Scale (mRS) at Discharge and 90 Days	90 days	The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. A score of 0 is a patient with no residual symptoms. Scores increase with severity to 5 which equals severe disability.

Trial Locations

Locations (5)

Presbyterian Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Prisma Health Upstate; 🇺🇸 Greenville, South Carolina, United States

Swedish Medical Center Healthone; 🇺🇸 Englewood, Colorado, United States

Mount Sinai Hospital (Neurosurgery); 🇺🇸 New York, New York, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States