Bladder ARFI Study

This study is currently recruiting participants.

Verified January 2013 by University of Michigan

Sponsor:

Information provided by (Responsible Party):

Jonathan R. Dillman M.D., University of Michigan

ClinicalTrials.gov Identifier:

NCT01781832

First received: January 30, 2013

Last updated: NA

Last verified: January 2013

History: No changes posted

Purpose

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.

Condition	Intervention
Bladder Fibrosis	Device: ARFI-Derived Shear Wave Velocities

Study Type:	Interventional
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

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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.

Estimated Enrollment:	30
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)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or younger
Your physician has ordered urodynamic testing -

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781832

Contacts

Contact: Jonathan Dillman, M.D.	734-232-9247
Contact: James Pool, Jr., CCRC	734-615-7391	jampool@umich.edu

Locations

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 jampool@umich.edu
Principal Investigator: Jonathan Dillman, M.D.

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:

Jonathan Dillman, M.D.

University of Michigan Hospital

More Information

No publications provided

Responsible Party:	Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier:	NCT01781832 History of Changes
Other Study ID Numbers:	HUM00064416
Study First Received:	January 30, 2013
Last Updated:	January 30, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013

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