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

This study has been terminated.
(Sponsor decision to close trial)
Sponsor:
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier:
NCT01927575
First received: August 20, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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 Intervention
Wrist Injury
Tibial Fracture
Hip Injury
Device: TOMO
Device: Standard X-Ray
Device: Standard CT Scan or MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis

Resource links provided by NLM:


Further study details as provided by Fujifilm Medical Systems USA, Inc.:

Primary Outcome Measures:
  • Diagnostic Efficacy [ Time Frame: Baseline Imaging Collection ] [ Designated as safety issue: No ]
    Endpoint to determine if TOMO Imaging can replace or supplement current imaging standards to detect hip, wrist or tibia injuries.


Secondary Outcome Measures:
  • Radiation Reduction [ Time Frame: Baseline Imaging Collection ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard X-Ray
Standard of care X-Ray imaging to be compared with research imaging device.
Device: Standard X-Ray
Standard of Care X-Ray Imaging
Active Comparator: Standard CT Scan or MRI
Standard CT Scan or 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 CT Scan or MRI
Standard CT Scan or MRI Imaging - Physician/Site Discretion
Experimental: TOMO
Investigational arm to determine if imaging results can compliment or replace standard imaging devices at potential lower radiation doses.
Device: TOMO
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier: NCT01927575     History of Changes
Other Study ID Numbers: FMSU2012-001
Study First Received: August 20, 2013
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014