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Bladder ARFI (Acoustic Radiation Force Impulse) Study

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ClinicalTrials.gov Identifier: NCT01781832
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ethan Smith, University of Michigan

Brief Summary:
Urinary bladder fibrosis (thickening and scarring) is fairly 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 ultrasound scanning and ARFI (acoustic radiation force impulse) wave velocities to potentially identify any urinary bladder wall fibrosis.

Condition or disease Intervention/treatment
Bladder Fibrosis Device: ARFI-Derived Shear Wave Velocities

Detailed Description:

Urinary bladder fibrosis (thickening and scarring) is fairly uncommon in children. Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic testing.

We will use ultrasound 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 found within the bladder wall will increase with increasing evidence of fibrosis.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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
Study Start Date : October 2012
Primary Completion Date : October 2016
Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: (ARFI)-Derived Shear Wave Velocities

This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI). Shear Wave speeds are derived using ARFI.

During ultrasound scanning a sound wave is sent towards tissue. The tissue's movement in response to the wave is measured in Shear Wave Velocity, which can estimate tissue stiffness. This technique may help detect bladder wall thickness and fibrosis (thickening) in the urinary bladder of pediatric patients.

Device: ARFI-Derived Shear Wave Velocities
An ultrasound based scan uses ARFI, an acoustic radiation force impulse to estimate shear wave velocities during scanning of the urinary bladder. The research ultrasound scan lasts about 10 to 15 minutes.



Primary Outcome Measures :
  1. Shear Wave Velocity, VTQ [ Time Frame: Visit 0 ]
    Shear wave velocity VTQ, or Virtual Touch Quantification is a "point" method for measuring a tissue's stiffness. A stiffness value is obtained from only the area in which a region of interest is placed.

  2. Shear Wave Velocity (VITQ) [ Time Frame: Visit 0 ]
    Shear Wave Velocity, VITQ, or Virtual Touch Tissue Imaging quantification is a color 2D method for measuring a tissues's stiffness. A color image (elastogram) of stiffness is acquired using this method. Then, one or more regions of interest can be placed in the area of interest on the elastogram. VITQ regions of interest are smaller than those used by VTQ.



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:

  1. Adults
  2. Unwilling to sign consent form

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


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ethan Smith, M.D. University of Michigan Hospital

Responsible Party: Ethan Smith, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01781832     History of Changes
Other Study ID Numbers: HUM00064416
First Posted: February 1, 2013    Key Record Dates
Results First Posted: January 3, 2018
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes