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

Primary Purpose

Wrist Injury, Tibial Fracture, Hip Injury

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard X-Ray + CT

Standard X-Ray + MRI

TOMO

About this trial

This is an interventional diagnostic trial for Wrist Injury focused on measuring TOMOSYNTHESIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Loyola University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Standard X-Ray + CT

Standard X-Ray + MRI

Tomo

Arm 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.

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.

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01927575

First Posted

August 20, 2013

Last Updated

May 22, 2020

Sponsor

Fujifilm Medical Systems USA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01927575

Brief Title

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

Acronym

TOMO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to close trial

Study Start Date

September 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fujifilm Medical Systems USA, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wrist Injury, Tibial Fracture, Hip Injury

Keywords

TOMOSYNTHESIS

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard X-Ray + CT

Arm Type

Active Comparator

Arm 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.

Arm Title

Standard X-Ray + MRI

Arm Type

Active Comparator

Arm 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.

Arm Title

Tomo

Arm Type

Experimental

Arm Description

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Intervention Type

Device

Intervention Name(s)

Standard X-Ray + CT

Intervention Description

Standard of Care X-Ray Imaging + CT

Intervention Type

Device

Intervention Name(s)

Standard X-Ray + MRI

Intervention Description

Standard of Care X-Ray Imaging + MRI

Intervention Type

Device

Intervention Name(s)

TOMO

Intervention Description

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Primary Outcome Measure Information:

Title

Number of Participants for Whom Tibia Injury Was Detected

Description

Time Frame

Baseline Imaging Collection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Physician request to have diagnostic imaging for condition areas Exclusion Criteria: Under 18 Pregnancy Insufficient Anatomical Coverage or Potential Image Problems

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Davide Bova, MD

Organizational Affiliation

Loyola University Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola University of Chicago

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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