Distal Radius Fracture, Scaphoid Fracture
Conditions
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.
Interventions
DEVICEDTS
Subjects undergo wrist imaging using DTS.
DEVICEX-ray
Subjects undergo wrist imaging using standard X-ray imaging.
DEVICEMRI or CT
Subjects may undergo wrist imaging using MRI or CT.
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Control-arm Subjects: Subjects who meet all of the following inclusion criteria may be enrolled in this study: 1. Are adults aged 18 years or older; 2. Are able and willing to comply with study procedures; and 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMary Dooley
Backup ContactDavid Steinberg, MD
Outcome results
None listed