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Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study

Not Applicable
Conditions
Distal Radius Fracture
Scaphoid Fracture
Registration Number
NCT03856450
Lead Sponsor
GE Healthcare
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Number of CT (or MRI) images1 year

collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case

Number of DTS images1 year

Collection of image sets from DTS imaging exams for each complete and evaluable subject case

Number of X-ray Images1 year

collection of image sets from X-ray imaging exams for each complete and evaluable subject case

Secondary Outcome Measures
NameTimeMethod
Questionnaire about Diagnosis1 year

collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case

Questionnaire about Treatment1 year

collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case

Trial Locations

Locations (1)

University of Pennsylvania Hospital - Department of Orthopaedic Surgery

🇺🇸

Philadelphia, Pennsylvania, United States

University of Pennsylvania Hospital - Department of Orthopaedic Surgery
🇺🇸Philadelphia, Pennsylvania, United States
David Steinberg, MD
Contact
856-220-6985
David.Steinberg@uphs.upenn.edu
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