ADVANCE- Automated Detection and Volumetric Assessment of ICH

Study Overview
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Brief Summary
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To evaluate the performance of the Viz ICH VOLUME algorithm.

Detailed Description
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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.

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

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Device: Viz ICH VOLUME


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Viz ICH VOLUME<br>Patient data collected prior to Viz ICH VOLUME implementation, utilized as a control data set | |
| Post-Viz ICH VOLUME<br>Patient data collected post-Viz ICH VOLUME implementation | Device: Viz ICH VOLUME<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algorithm Performance | Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation. | Up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algorithm Processing Time | Total run time in minutes for the algorithm to process the CT scan following receipt | Up to 10 minutes | 
| Time to Notification | Time in minutes from CT imaging to time an interventionalist was notified | Up to 10 minutes | 
| Time to Treatment | Time in minutes from CT imaging to start time of treatment | up to 1 day (1440 minutes) | 
| Length of Stay | Number of days in hospital | Hospital admit to discharge, up to 30 days | 
| In Hospital Complications | Occurrence of stroke-related or stroke treatment-related complications while in hospital | Hospital admit to discharge, up to 30 days | 
| Modified Rankin Scale (mRS) at Discharge and 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. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, ICH