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

Tibial Fracture Clinical Trial

— TOMO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01927575
• Other study ID #: FMSU2012-001
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2020
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Physician request to have diagnostic imaging for condition areas

Exclusion Criteria:

• Under 18

• Pregnancy

• Insufficient Anatomical Coverage or Potential Image Problems

Related Conditions & MeSH terms

• Hip Injuries
• Hip Injury
• Tibial Fracture
• Tibial Fractures
• Wounds and Injuries
• Wrist Injuries
• Wrist Injury

Intervention

Device:
• Standard X-Ray + CT
Standard of Care X-Ray Imaging + CT
• Standard X-Ray + MRI
Standard of Care X-Ray Imaging + MRI
• TOMO
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Locations

Country	Name	City	State
United States	Loyola University of Chicago	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants for Whom Tibia Injury Was Detected	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.	Baseline Imaging Collection