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Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion

NCT03030872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2018-11-14

No results posted yet for this study

Summary

The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device"). Therefore, there will be several separate objectives depending on the type of acquisition:

Conditions

  • Ischemia

Interventions

DEVICE

Investigational software

The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation.

Sponsors & Collaborators

  • Carestream Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Pate, MS, RN · Senior Manager Clinical Affairs

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-07
Primary Completion
2017-01-12
Completion
2017-01-12
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03030872 on ClinicalTrials.gov