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The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed Tomography (CT) Perfusion ("investigational device") imaging performance. Evaluation of CT Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with CT Perfusion Module.
This study will demonstrate the imaging performance CTP by an assessment of 30 CTP de-identified patient cases collected retrospectively. The purpose of the study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images.
The maps include the following:
The retrospective data collected for each patient will include a non-contrast head CT exam completed on the same day as CTP image, and a follow-up head CT at least 1-2 days after the initial imaging study (initial non-contrast head CT) if available.
Similar performance between the investigational and predicate devices was demonstrated by the following criteria.
i. Substantial equivalence of the perfusion maps between devices ii. Substantial equivalence of the core and penumbra tissues resulting from thresholds on the perfusion maps between devices iii. The clinical decision based on the exclusion or inclusion criteria for treatment is equivalent between devices
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicate software | Olea Sphere PACS with CT Perfusion Module | ||
| Investigational software | Vue PACS 12.1.5 Computed Tomography (CT) Perfusion |
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| Measure | Description | Time Frame |
|---|---|---|
| To compare the diagnostic value of CTP in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with CT Perfusion Module ("predicate device"). | Demonstrate equivalent clinical quality between the investigational and predicate devices. | one month |
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Inclusion Criteria:
Exclusion Criteria:
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Thirty retrospective CT perfusion (CTP) cases that include the collection of CTP original data, perfusion maps and 2 non-contrast head CTs.
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| Name | Affiliation | Role |
|---|---|---|
| Ayelet Eran, MD | Rambam Health Care Campus | Principal Investigator |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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