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

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FujiFilm

Status

Terminated

Conditions

Hip Injury
Tibial Fracture
Wrist Injury

Treatments

Device: Standard X-Ray + MRI
Device: TOMO
Device: Standard X-Ray + CT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01927575
FMSU2012-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Physician request to have diagnostic imaging for condition areas

Exclusion criteria

  • Under 18
  • Pregnancy
  • Insufficient Anatomical Coverage or Potential Image Problems

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

1 participants in 3 patient groups

Standard X-Ray + CT
Active Comparator group
Description:
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.
Treatment:
Device: TOMO
Device: Standard X-Ray + CT
Standard X-Ray + MRI
Active Comparator group
Description:
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.
Treatment:
Device: TOMO
Device: Standard X-Ray + MRI
Tomo
Experimental group
Description:
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Treatment:
Device: TOMO
Device: Standard X-Ray + MRI
Device: Standard X-Ray + CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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