ADVANCE- Automated Detection and Volumetric Assessment of ICH

CompletedOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

April 15, 2023

Study Completion Date

April 28, 2023

Conditions
Intracerebral Hemorrhage
Interventions
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.

Trial Locations (5)

10029

Mount Sinai Hospital (Neurosurgery), New York

27103

Forsyth Medical Center, Winston-Salem

28204

Presbyterian Medical Center, Charlotte

29605

Prisma Health Upstate, Greenville

80113

Swedish Medical Center Healthone, Englewood

All Listed Sponsors
lead

Viz.ai, Inc.

INDUSTRY

NCT04733638 - ADVANCE- Automated Detection and Volumetric Assessment of ICH | Biotech Hunter | Biotech Hunter