Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the performance of the Viz ICH VOLUME algorithm.
To evaluate the performance of the Viz ICH VOLUME algorithm to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Viz ICH VOLUME | Patient data collected prior to Viz ICH VOLUME implementation, utilized as a control data set | ||
| Post-Viz ICH VOLUME | Patient data collected post-Viz ICH VOLUME implementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected acute stroke or intracranial hemorrhage
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Moleen Madziva | Director of Clinical Affairs at Viz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center Healthone | Englewood | Colorado | 80113 | United States | ||
| Mount Sinai Hospital (Neurosurgery) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| New York |
| New York |
| 10029 |
| United States |
| Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Prisma Health Upstate | Greenville | South Carolina | 29605 | United States |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |