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Impact of Volume Imaging Using Diagnostic Ultrasound

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ClinicalTrials.gov Identifier: NCT01601782
Recruitment Status : Terminated (It was determined that the volume imaging was not working.)
First Posted : May 18, 2012
Results First Posted : August 19, 2014
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jon Jacobson, University of Michigan

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

Condition or disease Intervention/treatment Phase
Bone Injuries Muscle Injuries Tendon Injuries Procedure: Ultrasound Scan Device: Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Volume Imaging With Ultrasound
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Volume Imaging scan
New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.
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.
Other Names:
  • Volumetric Ultrasound
  • 3D Ultrasound Imaging
  • Volume Imaging

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.




Primary Outcome Measures :
  1. Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601782


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jon Jacobson, M.D. University of Michigan Hospital

Responsible Party: Jon Jacobson, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01601782     History of Changes
Other Study ID Numbers: HUM00030780
First Posted: May 18, 2012    Key Record Dates
Results First Posted: August 19, 2014
Last Update Posted: January 19, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Wounds and Injuries
Tendon Injuries