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NCT01601782 Clinical Trial

Impact of Volume Imaging Using Diagnostic Ultrasound

Tendon Injuries Clinical Trial

Official title:
Impact of Volume Imaging With Ultrasound

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01601782
Other study ID # HUM00030780
Secondary ID
Status Terminated
Phase N/A
First received May 1, 2012
Last updated December 19, 2017
Start date August 2009
Est. completion date May 2010

Study information
Verified date December 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine if volume imaging can diagnose bone, ligament, muscle injuries.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date May 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound Scan
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.
Device:
• Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
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.

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 13 minutes
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