To evaluate the performance of the Viz ICH VOLUME algorithm.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Swedish Medical Center Healthone
Englewood, Colorado, United States
Mount Sinai Hospital (Neurosurgery)
New York, New York, United States
Presbyterian Medical Center
Charlotte, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Algorithm Performance
Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.
Time frame: Up to 10 minutes
Algorithm Processing Time
Total run time in minutes for the algorithm to process the CT scan following receipt
Time frame: Up to 10 minutes
Time to Notification
Time in minutes from CT imaging to time an interventionalist was notified
Time frame: Up to 10 minutes
Time to Treatment
Time in minutes from CT imaging to start time of treatment
Time frame: up to 1 day (1440 minutes)
Length of Stay
Number of days in hospital
Time frame: Hospital admit to discharge, up to 30 days
In Hospital Complications
Occurrence of stroke-related or stroke treatment-related complications while in hospital
Time frame: 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.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Prisma Health Upstate
Greenville, South Carolina, United States