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| Name | Class |
|---|---|
| Nico Corporation | INDUSTRY |
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To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.
This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Active Comparator | Subject CT images assessed by Viz RECRUIT software in "real time" analysis All subjects in which the Viz RECRUIT software is utilized will be identified per cohort described below per PI confirmation of ENRICH Trial status/Study ID. Cohort A: Subjects with imaging data Cohort B: Subjects with imaging data and ultimately enrolled as part of the ENRICH Trial |
|
| Control Arm | No Intervention | Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viz RECRUIT | Device | Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH. | Enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian T Jankowitz, MD | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Medical Center | Little Rock | Arkansas | 72205 | United States | ||
| Northshore University Health System |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Evanston |
| Illinois |
| 60201 |
| United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| SUNY Buffalo | Buffalo | New York | 14203 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |