Impact of Volume Imaging Using Diagnostic Ultrasound
Determine if volume imaging can diagnose bone, ligament, muscle injuries.
Procedure: Ultrasound Scan
Device: Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).
|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|
- 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.
|Study Start Date:||August 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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: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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601782
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Jon Jacobson, M.D.||University of Michigan Hospital|