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

General Electric (GE)

Status: Unknown

Conditions: Distal Radius Fracture; Scaphoid Fracture

Treatments: Device: X-ray; Device: DTS; Device: MRI or CT

Study type: Interventional

Funder types: Industry

Identifiers

NCT03856450

124.02-2018-GES-0001

Details and patient eligibility

About

The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 exclusion criteria will be excluded from this study:

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.

Inclusion Criteria for Test-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. 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 for Test-arm Subjects:

Subjects who meet any of the following exclusion criteria will be excluded from this study:

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Control-arm group

Active Comparator group

Description:

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.

Treatment:

Device: DTS

Device: X-ray

Test-arm group

Experimental group

Description:

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.

Treatment:

Device: MRI or CT

Device: DTS

Device: X-ray