Trials / Unknown
UnknownNCT03856450
Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-12-20
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2019-02-27
- Last updated
- 2020-09-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03856450. Inclusion in this directory is not an endorsement.