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Bladder ARFI (Acoustic Radiation Force Impulse) Study

This study is currently recruiting participants.
Verified September 2016 by Ethan Smith, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781832
First Posted: February 1, 2013
Last Update Posted: September 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethan Smith, University of Michigan
  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: Intervention Model: Single Group Assignment
Masking: None (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 Ethan Smith, University of Michigan:

Primary Outcome Measures:
  • ARFI-Derived Shear Wave Velocities [ Time Frame: 6 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 30, 2013
First Posted: February 1, 2013
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes


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