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Impact of Volume Imaging Using Diagnostic Ultrasound

This study has been terminated.
(It was determined that the volume imaging was not working.)
Sponsor:
Information provided by (Responsible Party):
Jon Jacobson, University of Michigan
ClinicalTrials.gov Identifier:
NCT01601782
First received: May 1, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Bone Injuries
Muscle Injuries
Tendon Injuries
Procedure: Ultrasound Scan
Device: Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Volume Imaging With Ultrasound

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Volume Imaging Assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    Determine if volume imaging can accurately diagnose muscle, bone and tendon injuries when compared to conventional x-ray scan.

    The goal of the study is to determine if a diagnosis can be provided by reviewing a 3D data set of ultrasound images that are focused at a patient's site of maximal symptoms. The hypothesis was whether this simple technique using innovative 3D imaging could replace the more time-consuming manual scanning of a patient's extremity.


  • Accuracy of 3D Ultrasound Scanning [ Time Frame: Up to 13 minutes ] [ Designated as safety issue: No ]
    5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan. Both 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. We found in every case that there was no value so we immediately scrapped the project.


Enrollment: 16
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jon Jacobson, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01601782     History of Changes
Other Study ID Numbers: HUM00030780
Study First Received: May 1, 2012
Results First Received: December 10, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014