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Bladder ARFI (Acoustic Radiation Force Impulse) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Ethan Smith, University of Michigan
ClinicalTrials.gov Identifier:
NCT01781832
First received: January 30, 2013
Last updated: September 8, 2016
Last verified: September 2016
  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. In this study we will use ARFI (acoustic radiation force impulse)-derived shear wave velocities to potentially identify any urinary bladder wall 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: July 2017
Estimated Primary Completion Date: June 2017 (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.

Detailed Description:
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 will use ARFI (acoustic radiation force impulse)-derived shear wave velocities to potentially 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.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or younger
  2. Have an order for urodynamic testing from your doctor

Exclusion Criteria:

  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: NCT01781832

Contacts
Contact: Ethan Smith, M.D. 734-232-9245 ethans@med.umich.edu
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: Ethan Smith, M.D.    734-232-9245    ethans@med.umich.edu   
Contact: James Pool Jr., CCRC    734-615-7391    jampool@umich.edu   
Principal Investigator: Ethan Smith, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ethan Smith, M.D. University of Michigan Hospital
  More Information

Responsible Party: Ethan Smith, 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: September 8, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016