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

NCT ID: NCT01927575

Last Updated: 2020-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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

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Wrist Injury Tibial Fracture Hip Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard X-Ray + CT

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.

Group Type ACTIVE_COMPARATOR

Standard X-Ray + CT

Intervention Type DEVICE

Standard of Care X-Ray Imaging + CT

TOMO

Intervention Type DEVICE

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Standard X-Ray + MRI

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.

Group Type ACTIVE_COMPARATOR

Standard X-Ray + MRI

Intervention Type DEVICE

Standard of Care X-Ray Imaging + MRI

TOMO

Intervention Type DEVICE

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Tomo

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Group Type EXPERIMENTAL

Standard X-Ray + CT

Intervention Type DEVICE

Standard of Care X-Ray Imaging + CT

Standard X-Ray + MRI

Intervention Type DEVICE

Standard of Care X-Ray Imaging + MRI

TOMO

Intervention Type DEVICE

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Interventions

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Standard X-Ray + CT

Standard of Care X-Ray Imaging + CT

Intervention Type DEVICE

Standard X-Ray + MRI

Standard of Care X-Ray Imaging + MRI

Intervention Type DEVICE

TOMO

Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Physician request to have diagnostic imaging for condition areas

Exclusion Criteria

* Under 18
* Pregnancy
* Insufficient Anatomical Coverage or Potential Image Problems
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujifilm Medical Systems USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davide Bova, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

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Loyola University of Chicago

Maywood, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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FMSU2012-001

Identifier Type: -

Identifier Source: org_study_id

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