Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- GE Healthcare
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Number of CT (or MRI) images
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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 X-ray Images
Time Frame: 1 year
collection of image sets from X-ray imaging exams for each complete and evaluable subject case
Secondary Outcomes
- Questionnaire about Diagnosis(1 year)
- Questionnaire about Treatment(1 year)