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

NCT01927575 | Terminated Results

• 1 other identifier: FMSU2012-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrist Injury; Tibial Fracture; Hip Injury

Keywords

TOMOSYNTHESIS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Standard X-Ray + CT

ACTIVE COMPARATOR

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; Device: TOMO

Standard X-Ray + MRI

ACTIVE COMPARATOR

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; Device: TOMO

Tomo

EXPERIMENTAL

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

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

Interventions

Standard X-Ray + CT DEVICE

Standard of Care X-Ray Imaging + CT

Standard X-Ray + CT; Tomo

Standard X-Ray + MRI DEVICE

Standard of Care X-Ray Imaging + MRI

Standard X-Ray + MRI; Tomo

TOMO DEVICE

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Standard X-Ray + CT; Standard X-Ray + MRI; Tomo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician request to have diagnostic imaging for condition areas

You may not qualify if:

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

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (1)

Loyola University of Chicago

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Wrist Injuries; Tibial Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone; Leg Injuries

Results Point of Contact

• Title: Robert Uzenoff
• Organization: Fujifilm Medical Systems, U.S.A., Inc.

ruzenoff@fujifilm.com

(203) 602-3664

Study Officials

• Davide Bova, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 22, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 4, 2020
• Results First Posted: June 5, 2017

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)