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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03856450
• Other study ID #: 124.02-2018-GES-0001
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2020
• Source: GE Healthcare
• Contact: Mary Dooley
• Phone: (215)-294-9650
• Email: Mary.Dooley[@]uphs.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Scaphoid Fracture

Intervention

Device:
• DTS
Subjects undergo wrist imaging using DTS.
• X-ray
Subjects undergo wrist imaging using standard X-ray imaging.
• MRI or CT
Subjects may undergo wrist imaging using MRI or CT.

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital - Department of Orthopaedic Surgery	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of X-ray Images	collection of image sets from X-ray imaging exams for each complete and evaluable subject case	1 year
Primary	Number of DTS images	Collection of image sets from DTS imaging exams for each complete and evaluable subject case	1 year
Primary	Number of CT (or MRI) images	collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case	1 year
Secondary	Questionnaire about Diagnosis	collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case	1 year
Secondary	Questionnaire about Treatment	collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case	1 year