Wrist InjuryTOMONCT01927575
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
A study testing Standard X-Ray + CT, Standard X-Ray + MRI and TOMO in people with Wrist Injury and Tibial Fracture, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Injury, Tibial Fracture, Hip Injury
- What is being tested?
- Standard X-Ray + CT, Standard X-Ray + MRI and TOMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician request to have diagnostic imaging for condition areas
Who cannot join
- Under 18
- Pregnancy
- Insufficient Anatomical Coverage or Potential Image Problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University of Chicago
Maywood, Illinois, 60153
About this study
Official title: Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis
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.
Read the 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.
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Being tested
- Standard X-Ray + CT, Standard X-Ray + MRI, TOMO
- Keywords
- TOMOSYNTHESIS
- Medical subject headings
- Wrist Injuries, Tibial Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard X-Ray + CTDevice
Standard of Care X-Ray Imaging + CT
Standard X-Ray + MRIDevice
Standard of Care X-Ray Imaging + MRI
TOMODevice
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard X-Ray + MRI; Device: TOMO |
| Tomo | Experimental | Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis Receives: Device: Standard X-Ray + CT; Device: Standard X-Ray + MRI; Device: TOMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Imaging Collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Sponsor decision to close trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wrist InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davide Bova, MD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927575
- Sponsor's protocol ID
- FMSU2012-001
- Acronym
- TOMO
- Status last verified
- May 2020
- First submitted
- 20 Aug 2013
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis
- ClinicalTrials.gov ID
- NCT01927575
- Acronym / sponsor ID
- TOMO / FMSU2012-001
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Keywords
- TOMOSYNTHESIS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to close trial
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard X-Ray + CT | Active comparator | Device: Standard X-Ray + CT, Device: TOMOStandard 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 | Active comparator | Device: Standard X-Ray + MRI, Device: TOMOStandard 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. |
| Tomo | Experimental | Device: Standard X-Ray + CT, Device: Standard X-Ray + MRI, Device: TOMOFujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physician request to have diagnostic imaging for condition areas
Key exclusion criteria (3 listed)
- Under 18
- Pregnancy
- Insufficient Anatomical Coverage or Potential Image Problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard X-Ray + CTStandard of Care X-Ray Imaging + CT | Device | Standard X-Ray + CT, Tomo |
| Standard X-Ray + MRIStandard of Care X-Ray Imaging + MRI | Device | Standard X-Ray + MRI, Tomo |
| TOMOFujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis | Device | Standard X-Ray + CT, Standard X-Ray + MRI, Tomo |
Primary outcome
Number of Participants for Whom Tibia Injury Was Detected
Time frame: Baseline Imaging Collection
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Bova, MD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard X-Ray + CT, Standard X-Ray + MRI and TOMO in people with Wrist Injury and Tibial Fracture, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Whom Tibia Injury Was Detected (time frame: Baseline Imaging Collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.