ADVANCE- Automated Detection and Volumetric Assessment of ICH

Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study

To evaluate the performance of the Viz ICH VOLUME algorithm.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center Healthone
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital (Neurosurgery)
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Upstate

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected acute stroke or intracranial hemorrhage

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algorithm Performance	Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.	Up to 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS) at Discharge and 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.	90 days
Algorithm Processing Time	Total run time in minutes for the algorithm to process the CT scan following receipt	Up to 10 minutes
Time to Notification	Time in minutes from CT imaging to time an interventionalist was notified	Up to 10 minutes
Time to Treatment	Time in minutes from CT imaging to start time of treatment	up to 1 day (1440 minutes)
Length of Stay	Number of days in hospital	Hospital admit to discharge, up to 30 days
In Hospital Complications	Occurrence of stroke-related or stroke treatment-related complications while in hospital	Hospital admit to discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Viz.ai, Inc.
• Investigators: Study Director: Moleen Madziva, Director of Clinical Affairs at Viz

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 2, 2021

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-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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