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Completed

NCT Number: NCT01781832

Bladder ARFI (Acoustic Radiation Force Impulse) Study

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.

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Key information

Conditions

Bladder Fibrosis

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or younger
  • Have an order for urodynamic testing from your doctor

Exclusion criteria

  • Adults
  • Unwilling to sign consent form

Treatment and study plan

ARFI-Derived Shear Wave Velocities

Device

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Evaluation of Pediatric Urinary Bladder Wall Thickening and Fibrosis Using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocities

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2013
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.