Clinical Trial: Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis

Brief Summary: To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

Detailed Summary: Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.
Sponsor: Fujifilm Medical Systems USA, Inc.

Current Primary Outcome: Diagnostic Efficacy [ Time Frame: Baseline Imaging Collection ]

Endpoint to determine if TOMO Imaging can replace or supplement current imaging standards to detect hip, wrist or tibia injuries.


Original Primary Outcome: Same as current

Current Secondary Outcome: Radiation Reduction [ Time Frame: Baseline Imaging Collection ]

To assess if a reduction in radiation dose can be achieved in the TOMO group as compared to imaging standards with equal or better injury detection rates from TOMO imaging.


Original Secondary Outcome: Same as current

Information By: Fujifilm Medical Systems USA, Inc.

Dates:
Date Received: August 20, 2013
Date Started: September 2013
Date Completion:
Last Updated: May 22, 2014
Last Verified: May 2014