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Completed

NCT Number: NCT04733638

ADVANCE- Automated Detection and Volumetric Assessment of ICH

To evaluate the performance of the Viz ICH VOLUME algorithm.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Medical Center Healthone, Englewood, Colorado, United States

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About this study

To evaluate the performance of the Viz ICH VOLUME algorithm to:

  • detect the presence of ICH on brain imaging,
  • measure the volume of ICH on brain imaging,
  • and to assess the algorithm processing time,
  • and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Algorithm Performance

    Time frame: Up to 10 minutes

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

Secondary outcomes

  1. Algorithm Processing Time

    Time frame: Up to 10 minutes

    Total run time in minutes for the algorithm to process the CT scan following receipt

  2. Time to Notification

    Time frame: Up to 10 minutes

    Time in minutes from CT imaging to time an interventionalist was notified

  3. Time to Treatment

    Time frame: up to 1 day (1440 minutes)

    Time in minutes from CT imaging to start time of treatment

  4. Length of Stay

    Time frame: Hospital admit to discharge, up to 30 days

    Number of days in hospital

  5. In Hospital Complications

    Time frame: Hospital admit to discharge, up to 30 days

    Occurrence of stroke-related or stroke treatment-related complications while in hospital

  6. Modified Rankin Scale (mRS) at Discharge and 90 Days

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Viz.ai, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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