Back to resultsImpact of Volume Imaging Using Diagnostic Ultrasound
Primary Purpose
Bone Injuries, Muscle Injuries, Tendon Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Scan
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone Injuries
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.
Exclusion Criteria:
- Unable to lie flat on ultrasound table.
- Subjects under 18 years of age
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Volume Imaging scan
Arm Description
New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Outcomes
Primary Outcome Measures
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging
Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601782
Brief Title
Impact of Volume Imaging Using Diagnostic Ultrasound
Official Title
Impact of Volume Imaging With Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
It was determined that the volume imaging was not working.
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Determine if volume imaging can diagnose bone, ligament, muscle injuries.
Detailed Description
The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Injuries, Muscle Injuries, Tendon Injuries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volume Imaging scan
Arm Type
Experimental
Arm Description
New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Scan
Other Intervention Name(s)
Volumetric Ultrasound, 3D Ultrasound Imaging, Volume Imaging
Intervention Description
Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician.
Intervention Type
Device
Intervention Name(s)
Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
Intervention Description
The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries.
Primary Outcome Measure Information:
Title
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging
Description
Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.
Time Frame
Up to 13 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.
Exclusion Criteria:
Unable to lie flat on ultrasound table.
Subjects under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Jacobson, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Volume Imaging Using Diagnostic Ultrasound
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