An interventional study of Standard X-Ray + CT and Standard X-Ray + MRI in Wrist Injury, Tibial Fracture and Hip Injury, sponsored by Fujifilm Medical Systems USA, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Fujifilm Medical Systems USA, Inc. · Not applicable, Interventional, and Diagnostic
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.
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.
46 studies on the registry are indexed under Wrist Injuries; 12 are open to participants now.
This study's enrollment of 1 is below the median of 53 across 32 interventional studies indexed under Wrist Injuries.
Browse Wrist Injuries studies →Fujifilm Medical Systems USA, Inc. is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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 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
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Device: Standard X-Ray + CT · Device: Standard X-Ray + MRI · Device: TOMO
Standard of Care X-Ray Imaging + CT
Standard of Care X-Ray Imaging + MRI
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
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.
Time frame: Baseline Imaging Collection
Subjects who present for, are undergoing, or have undergone 'standard of care' general x-ray and CT or MRI examinations, which meet all of the study enrollment criteria, may be approached and enrolled. Each subject would then have a 3rd image taken using Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.
| Milestone | All Study Participants |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
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.
| participants | Standard X-Ray | Standard CT | Tomosynthesis |
|---|---|---|---|
| Number of Participants for Whom Tibia Injury Was Detected | 1 | 1 | 1 |
Collected over 1 day; Standard of Care X-ray, CT and Tomo all completed within this day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard X-Ray | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Standard CT | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Tomo | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
1 patient was enrolled in this study, and they underwent Standard X-Ray and CT as well as Tomosynthesis.
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 54 ± NA |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 0 |
| Male | 1 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Sep 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 3 years 2 months after primary completion.
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This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Fujifilm Medical Systems USA, Inc.