ADVANCE- Automated Detection and Volumetric Assessment of ICH

• Sponsor: Viz.ai, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04733638
• Collaborator: (none)
• Enrollment: 500
• Locations: 5
• Anticipated Duration (Months): 24.2
• Patients Per Site: 100
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

To evaluate the performance of the Viz ICH VOLUME algorithm.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Device: Viz ICH VOLUME

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study
• Actual Study Start Date: Jan 26, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Pre-Viz ICH VOLUME Patient data collected prior to Viz ICH VOLUME implementation, utilized as a control data set
Post-Viz ICH VOLUME Patient data collected post-Viz ICH VOLUME implementation	Device: Viz ICH VOLUME; Viz ICH VOLUME software is a module that identifies and segments Intraparenchymal Hemorrhage (IPH) from NCCT imaging. This software is for investigational use in the study and is not FDA cleared. For subjects who undergo a brain scan, Viz will use deep learning algorithms to analyze computed tomography (CT) or magnetic resonance (MR) images of the brain for ICH in parallel to standard of care image interpretation. If a suspected ICH is detected, Viz will perform an automatic volumetric analysis and will send a notification to a specialist, such as a neurointerventionalist or a neurosurgeon. Notifications prompt the specialist to review the patient's case. Additionally, non-diagnostic previewing of DICOM images, and HIPAA-compliant text messaging and phone calls are available in the software platform. Viz ICH VOLUME is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man.

Outcome Measures

Primary Outcome Measures

1. 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

1. Algorithm Processing Time [Up to 10 minutes]

   Total run time in minutes for the algorithm to process the CT scan following receipt

2. Time to Notification [Up to 10 minutes]

   Time in minutes from CT imaging to time an interventionalist was notified

3. Time to Treatment [up to 1 day (1440 minutes)]

   Time in minutes from CT imaging to start time of treatment

4. Length of Stay [Hospital admit to discharge, up to 30 days]

   Number of days in hospital

5. In Hospital Complications [Hospital admit to discharge, up to 30 days]

   Occurrence of stroke-related or stroke treatment-related complications while in hospital

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swedish Medical Center Healthone	Englewood	Colorado	United States	80113
2	Mount Sinai Hospital (Neurosurgery)	New York	New York	United States	10029
3	Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
4	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
5	Prisma Health Upstate	Greenville	South Carolina	United States	29605

Sponsors and Collaborators

• Viz.ai, Inc.

Investigators

• Study Director: Moleen Madziva, Director of Clinical Affairs at Viz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viz.ai, Inc.
• ClinicalTrials.gov Identifier: NCT04733638
• Other Study ID Numbers: Viz-ICH-02
• First Posted: Feb 2, 2021
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Viz.ai, Inc.: Artificial Intelligence; ICH
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Apr 27, 2022