NCT04733638

ADVANCE- Automated Detection and Volumetric Assessment of ICH

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Viz.ai, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-26
• Primary completion: 2023-04-15
• Completion: 2023-04-28
• First posted: 2021-02-02
• Last updated: 2024-09-19

Locations

5 sites across 1 country: United States