Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Study Details
Study Description
Brief Summary
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control-arm group 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. |
Device: DTS
Subjects undergo wrist imaging using DTS.
Other Names:
Device: X-ray
Subjects undergo wrist imaging using standard X-ray imaging.
Other Names:
|
| Experimental: Test-arm group 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. |
Device: DTS
Subjects undergo wrist imaging using DTS.
Other Names:
Device: X-ray
Subjects undergo wrist imaging using standard X-ray imaging.
Other Names:
Device: MRI or CT
Subjects may undergo wrist imaging using MRI or CT.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of X-ray Images [1 year]
collection of image sets from X-ray imaging exams for each complete and evaluable subject case
- Number of DTS images [1 year]
Collection of image sets from DTS imaging exams for each complete and evaluable subject case
- Number of CT (or MRI) images [1 year]
collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case
Secondary Outcome Measures
- Questionnaire about Diagnosis [1 year]
collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case
- Questionnaire about Treatment [1 year]
collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case
Eligibility Criteria
Criteria
Inclusion Criteria for Control-arm Subjects:
Subjects who meet all of the following inclusion criteria may be enrolled in this study:
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Are adults aged 18 years or older;
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Are able and willing to comply with study procedures; and
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Are able and willing to provide written informed consent to participate in this study.
Exclusion Criteria for Control-arm Subjects:
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.
Inclusion Criteria for Test-arm Subjects:
Subjects who meet all of the following inclusion criteria may be enrolled in this study:
-
Are adults aged 18 years or older;
-
Have a confirmed or suspected distal radius or scaphoid wrist fracture;
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Have completed an X-ray imaging exam per standard of care;
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Have a standard of care (SOC) CT or MRI exam ordered;
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Are able and willing to complete DTS imaging exam (if not already completed);
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Are able and willing to comply with study procedures; and
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Are able and willing to provide written informed consent to participate in this study.
Exclusion Criteria for Test-arm Subjects:
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania Hospital - Department of Orthopaedic Surgery | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- GE Healthcare
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 124.02-2018-GES-0001