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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03856450
Other study ID # 124.02-2018-GES-0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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