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

NCT ID: NCT03856450

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2021-09-01

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.

Conditions

Distal Radius Fracture; Scaphoid Fracture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control-arm group

The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment.

Group Type: ACTIVE_COMPARATOR

DTS

Intervention Type: DEVICE

Subjects undergo wrist imaging using DTS.

X-ray

Intervention Type: DEVICE

Subjects undergo wrist imaging using standard X-ray imaging.

Test-arm group

The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received.

Group Type: EXPERIMENTAL

DTS

Intervention Type: DEVICE

Subjects undergo wrist imaging using DTS.

X-ray

Intervention Type: DEVICE

Subjects undergo wrist imaging using standard X-ray imaging.

MRI or CT

Intervention Type: DEVICE

Subjects may undergo wrist imaging using MRI or CT.

Interventions

DTS

Subjects undergo wrist imaging using DTS.

Intervention Type: DEVICE

X-ray

Subjects undergo wrist imaging using standard X-ray imaging.

Intervention Type: DEVICE

MRI or CT

Subjects may undergo wrist imaging using MRI or CT.

Intervention Type: DEVICE

Other Intervention Names

Digital Tomosynthesis (DTS); X-ray imaging; Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)

Eligibility Criteria

Inclusion Criteria

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.

1. Are adults aged 18 years or older;

2. Have a confirmed or suspected distal radius or scaphoid wrist fracture;

3. Have completed an X-ray imaging exam per standard of care;

4. Have a standard of care (SOC) CT or MRI exam ordered;

5. Are able and willing to complete DTS imaging exam (if not already completed);

6. Are able and willing to comply with study procedures; and

7. Are able and willing to provide written informed consent to participate in this study.

Exclusion Criteria

1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;

2. Have had known prior trauma in either wrist.

1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;

2. Have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture;

3. Have had prior reconstructive surgery or fixation in the wrist.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania Hospital - Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Dooley

Role: CONTACT

Mary.Dooley@uphs.upenn.edu

(215)-294-9650

David Steinberg, MD

Role: CONTACT

David.Steinberg@uphs.upenn.edu

(856)-220-6985

Facility Contacts

David Steinberg, MD

Role: primary

David.Steinberg@uphs.upenn.edu

856-220-6985

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

124.02-2018-GES-0001

Identifier Type: -

Identifier Source: org_study_id