Impact of Volume Imaging Using Diagnostic Ultrasound

Not Applicable

Terminated

• Conditions: Muscle Injuries; Tendon Injuries; Bone Injuries
• Interventions: Procedure: Ultrasound Scan; Device: Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).

• Registration Number: NCT01601782
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-18
• Results First Submitted: 2013-12-10
• Results First Submitted QC: 2014-08-18
• Results First Posted: 2014-08-19
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

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Exclusion Criteria

• Unable to lie flat on ultrasound table.
• Subjects under 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volume Imaging scan	Ultrasound Scan	New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
Volume Imaging scan	Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).	New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.

Primary Outcome Measures

Name	Time	Method
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging	Up to 13 minutes	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States