Impact of Volume Imaging Using Diagnostic Ultrasound

NCT01601782 | Terminated Results

• 1 other identifier: HUM00030780
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Injuries; Muscle Injuries; Tendon Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Volume Imaging scan

EXPERIMENTAL

New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.

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

Interventions

Ultrasound Scan PROCEDURE

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.

Also known as: Volumetric Ultrasound, 3D Ultrasound Imaging, Volume Imaging

Volume Imaging scan

Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). DEVICE

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.

Volume Imaging scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Must be scheduled to have a musculoskeletal (bone, ligament, muscle, tendon) ultrasound performed as part of their routine clinical care.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Tendon Injuries

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Limitations and Caveats

16 patients were studied as part of a pilot project to determine if 3D ultrasound offers any benefit over routine standard ultrasound imaging of the extremity. The study was terminated after evaluating 16 subjects.

Results Point of Contact

• Title: Jon Jacobson, MD
• Organization: University of Michigan

jjacobsn@umich.edu

734-936-4365

Study Officials

• Jon Jacobson, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 18, 2012
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 19, 2018
• Results First Posted: August 19, 2014

Record last verified: 2017-12

Locations

US (1)