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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856450 on ClinicalTrials.gov