NCT01927575

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fujifilm Medical Systems USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Wrist Injury
• Tibial Fracture
• Hip Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-08-22
• Last updated: 2020-06-04
• Results posted: 2017-06-05

Locations

1 site across 1 country: United States