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ADVANCE- Automated Detection and Volumetric Assessment of ICH

NCT04733638 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-09-19

No results posted yet for this study

Summary

To evaluate the performance of the Viz ICH VOLUME algorithm.

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.

Sponsors & Collaborators

  • Viz.ai, Inc.

    lead INDUSTRY

Principal Investigators

  • Moleen Madziva · Director of Clinical Affairs at Viz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2023-04-15
Completion
2023-04-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733638 on ClinicalTrials.gov