Intracerebral Hemorrhage
Conditions
Keywords
Artificial Intelligence, ICH
Brief 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.
Interventions
DEVICEViz 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
Viz.ai, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Algorithm Performance | Up to 10 minutes | Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Notification | Up to 10 minutes | Time in minutes from CT imaging to time an interventionalist was notified |
| Time to Treatment | up to 1 day (1440 minutes) | Time in minutes from CT imaging to start time of treatment |
| Algorithm Processing Time | Up to 10 minutes | Total run time in minutes for the algorithm to process the CT scan following receipt |
| In Hospital Complications | Hospital admit to discharge, up to 30 days | Occurrence of stroke-related or stroke treatment-related complications while in hospital |
| Modified Rankin Scale (mRS) at Discharge and 90 Days | 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. |
| Length of Stay | Hospital admit to discharge, up to 30 days | Number of days in hospital |
Countries
United States
Outcome results
None listed