ADVANCE- Automated Detection and Volumetric Assessment of ICH

NCT04733638 | Completed

• 1 other identifier: Viz-ICH-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the performance of the Viz ICH VOLUME algorithm.

Conditions

Intracerebral Hemorrhage

Keywords

Artificial Intelligence; ICH

Outcome Measures

Primary Outcomes (1)

• Algorithm Performance

  Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.

  Up to 10 minutes

Secondary Outcomes (6)

• Algorithm Processing Time

  Up to 10 minutes

• Time to Notification

  Up to 10 minutes

• Time to Treatment

  up to 1 day (1440 minutes)

• Length of Stay

  Hospital admit to discharge, up to 30 days

• In Hospital Complications

  Hospital admit to discharge, up to 30 days

Study Arms (2)

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

Interventions

Viz ICH VOLUME DEVICE

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.

Post-Viz ICH VOLUME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Subjects with poor or incomplete brain imaging.

Sponsors & Collaborators

• Viz.ai, Inc.: lead

Study Sites (5)

Swedish Medical Center Healthone

Englewood, Colorado, 80113, United States

Location

Mount Sinai Hospital (Neurosurgery)

New York, New York, 10029, United States

Location

Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moleen Madziva

  Director of Clinical Affairs at Viz

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: January 26, 2021
• Primary Completion: April 15, 2023
• Study Completion: April 28, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (5)