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Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury (TOMO)

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ClinicalTrials.gov Identifier: NCT01927575
Recruitment Status : Terminated (Sponsor decision to close trial)
First Posted : August 22, 2013
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Wrist Injury Tibial Fracture Hip Injury Device: Standard X-Ray + CT Device: Standard X-Ray + MRI Device: TOMO

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis
Study Start Date : September 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Standard X-Ray + CT
Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Device: Standard X-Ray + CT
Standard of Care X-Ray Imaging + CT
Device: TOMO
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Active Comparator: Standard X-Ray + MRI
Standard X-Ray + MRI arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Device: Standard X-Ray + MRI
Standard of Care X-Ray Imaging + MRI
Device: TOMO
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Experimental: Tomo
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Device: Standard X-Ray + CT
Standard of Care X-Ray Imaging + CT
Device: Standard X-Ray + MRI
Standard of Care X-Ray Imaging + MRI
Device: TOMO
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis


Outcome Measures

Primary Outcome Measures :
  1. This Outcome Measure is Reporting the Number of Participants for Whom Hip, Wrist, or Tibia Injury Was Detected Using the TOMO as Well as Standard X-Ray and Standard CT [ Time Frame: Baseline Imaging Collection ]
    Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) [or designee] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician request to have diagnostic imaging for condition areas

Exclusion Criteria:

  • Under 18
  • Pregnancy
  • Insufficient Anatomical Coverage or Potential Image Problems
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927575


Locations
United States, Illinois
Loyola University of Chicago
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
Investigators
Principal Investigator: Davide Bova, MD Loyola University of Chicago
More Information

Responsible Party: Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier: NCT01927575     History of Changes
Other Study ID Numbers: FMSU2012-001
First Posted: August 22, 2013    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fujifilm Medical Systems USA, Inc.:
TOMOSYNTHESIS

Additional relevant MeSH terms:
Wounds and Injuries
Tibial Fractures
Wrist Injuries
Hip Injuries
Fractures, Bone
Leg Injuries
Arm Injuries