Distal Radius FractureNCT03856450
Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
A study testing DTS, X-ray and MRI or CT in people with Distal Radius Fracture and Scaphoid Fracture, run by GE Healthcare at 1 site in United States.
Trial summary
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Scaphoid Fracture
- What is being tested?
- DTS, X-ray and MRI or CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following inclusion criteria may be enrolled in this study:
- Are adults aged 18 years or older;
- Are able and willing to comply with study procedures; and
- Are able and willing to provide written informed consent to participate in this study.
- Subjects who meet all of the following inclusion criteria may be enrolled in this study:
- Are adults aged 18 years or older;
Show all 12Show fewer
- Have a confirmed or suspected distal radius or scaphoid wrist fracture;
- Have completed an X-ray imaging exam per standard of care;
- Have a standard of care (SOC) CT or MRI exam ordered;
- Are able and willing to complete DTS imaging exam (if not already completed);
- Are able and willing to comply with study procedures; and
- Are able and willing to provide written informed consent to participate in this study.
Who cannot join
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
- Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
- Have had known prior trauma in either wrist.
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
- Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
- Have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture;
- Have had prior reconstructive surgery or fixation in the wrist.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Hospital - Department of Orthopaedic Surgery
Philadelphia, Pennsylvania, 19104
David Steinberg, MD, 856-220-6985, David.Steinberg@uphs.upenn.edu
About this study
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
Read the detailed description
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States.
- Conditions
- Distal Radius Fracture, Scaphoid Fracture
- Being tested
- DTS, X-ray, MRI or CT
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTSDevice
Also called Digital Tomosynthesis (DTS)
Subjects undergo wrist imaging using DTS.
X-rayDevice
Also called X-ray imaging
Subjects undergo wrist imaging using standard X-ray imaging.
MRI or CTDevice
Also called Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)
Subjects may undergo wrist imaging using MRI or CT.
| Study group | Role | What they receive |
|---|---|---|
| Control-arm group | Active comparator | The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment. Receives: Device: DTS; Device: X-ray |
| Test-arm group | Experimental | The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received. Receives: Device: DTS; Device: X-ray; Device: MRI or CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of X-ray Images
collection of image sets from X-ray imaging exams for each complete and evaluable subject case
Measured: 1 year
Number of DTS images
Collection of image sets from DTS imaging exams for each complete and evaluable subject case
Measured: 1 year
Number of CT (or MRI) images
collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case
Measured: 1 year
Secondary outcomes (2)
Questionnaire about Diagnosis
collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case
Measured: 1 year
Questionnaire about Treatment
collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start20 Dec 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856450
- Sponsor's protocol ID
- 124.02-2018-GES-0001
- Status last verified
- Sep 2020
- First submitted
- 1 Feb 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
- ClinicalTrials.gov ID
- NCT03856450
- Acronym / sponsor ID
- 124.02-2018-GES-0001
- Conditions
- Distal Radius Fracture, Scaphoid Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
Detailed description
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-arm group | Active comparator | Device: DTS, Device: X-rayThe control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment. |
| Test-arm group | Experimental | Device: DTS, Device: X-ray, Device: MRI or CTThe test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Are adults aged 18 years or older;
- Are able and willing to comply with study procedures; and
- Are able and willing to provide written informed consent to participate in this study.
- Are adults aged 18 years or older;
- Have a confirmed or suspected distal radius or scaphoid wrist fracture;
Key exclusion criteria (7 listed)
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
- Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
- Have had known prior trauma in either wrist.
- Subjects who meet any of the following exclusion criteria will be excluded from this study:
- Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
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 |
|---|---|---|
| DTSAlso: Digital Tomosynthesis (DTS)Subjects undergo wrist imaging using DTS. | Device | Control-arm group, Test-arm group |
| X-rayAlso: X-ray imagingSubjects undergo wrist imaging using standard X-ray imaging. | Device | Control-arm group, Test-arm group |
| MRI or CTAlso: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)Subjects may undergo wrist imaging using MRI or CT. | Device | Test-arm group |
Primary outcome
Number of X-ray Images
Time frame: 1 year
collection of image sets from X-ray imaging exams for each complete and evaluable subject case
Number of DTS images
Time frame: 1 year
Collection of image sets from DTS imaging exams for each complete and evaluable subject case
Number of CT (or MRI) images
Time frame: 1 year
collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case
2 secondary outcomes
Questionnaire about Diagnosis
Time frame: 1 year
Questionnaire about Treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTS, X-ray and MRI or CT in people with Distal Radius Fracture and Scaphoid Fracture, run by GE Healthcare 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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Dooley ((215)-294-9650, Mary.Dooley@uphs.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of X-ray Images (time frame: 1 year). The study lists 3 primary outcomes in all. 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 30 Sep 2020.