Bladder ARFI Study
Urinary bladder fibrosis is relatively uncommon in children. Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic testing. We're will use ARFI (acoustic radiation force impulse)-derived shear wave velocities to hopefully identify the presence of urinary bladder wall fibrosis. We hypothesize that shear wave velocities obtained within the bladder wall will increase with increasing evidence of fibrosis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Pediatric Urinary Bladder Wall Thickening and Fibrosis Using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocities|
- ARFI-Derived Shear Wave Velocities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]That the measurements of the bladder wall thickness determined by the ARFI-Derived Shear Wave Velocities confirm bladder wall thickening and fibrosis.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: (ARFI)-Derived Shear Wave Velocities
This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients.
Device: ARFI-Derived Shear Wave Velocities
An ultrasound based scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan will take approximately 10 to 15 minutes to complete.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781832
|Contact: Jonathan Dillman, M.D.||734-232-9247|
|Contact: James Pool, Jr., CCRCfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Jonathan Dillman, M.D. 734-232-9247|
|Contact: James Pool Jr., CCRC 734-615-7391 email@example.com|
|Principal Investigator: Jonathan Dillman, M.D.|
|Principal Investigator:||Jonathan Dillman, M.D.||University of Michigan Hospital|