Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
NCT03856450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2020-09-30
Summary
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
Conditions
- Distal Radius Fracture
- Scaphoid Fracture
Interventions
- DEVICE
-
DTS
Subjects undergo wrist imaging using DTS.
- DEVICE
-
X-ray
Subjects undergo wrist imaging using standard X-ray imaging.
- DEVICE
-
MRI or CT
Subjects may undergo wrist imaging using MRI or CT.
Sponsors & Collaborators
-
GE Healthcare
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-20
- Primary Completion
- 2021-09-01
- Completion
- 2021-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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