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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2021

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.

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.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of X-ray Images
    • Time Frame: 1 year
    • collection of image sets from X-ray imaging exams for each complete and evaluable subject case
  • Number of DTS images
    • Time Frame: 1 year
    • Collection of image sets from DTS imaging exams for each complete and evaluable subject case
  • Number of CT (or MRI) images
    • Time Frame: 1 year
    • collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case

Secondary Measures

  • Questionnaire about Diagnosis
    • Time Frame: 1 year
    • collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case
  • Questionnaire about Treatment
    • Time Frame: 1 year
    • collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GE Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Mary Dooley, (215)-294-9650, Mary.Dooley@uphs.upenn.edu

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