Ischemia Clinical Trial
— CTPOfficial title:
CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol
NCT number | NCT02557282 |
Other study ID # | 9J8421 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | September 2015 |
Verified date | March 2018 |
Source | Carestream Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Retrospective patient CTP cases with case maps that include the following information: MTT, CBV, CBF, TTP, and TMAX. - Initial CT exam and CT exam 1-2 days after the initial exam if available, and - Retrospective CTP case with subject/patient 18 years of age or older Exclusion Criteria: - Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator, - Subject less than 18 years of age |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Carestream Health, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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