CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol

NCT02557282 | Completed

• 1 other identifier: 9J8421
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Predicate software

Olea Sphere PACS with CT Perfusion Module

Investigational software

Vue PACS 12.1.5 Computed Tomography (CT) Perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty retrospective CT perfusion (CTP) cases that include the collection of CTP original data, perfusion maps and 2 non-contrast head CTs.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carestream Health, Inc.: lead

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayelet Eran, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 23, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share