Bladder ARFI (Acoustic Radiation Force Impulse) Study

• 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: University of Michigan
• Information provided by (Responsible Party): Ethan Smith, University of Michigan

Tracking Information

• First Submitted Date: January 30, 2013
• First Posted Date: February 1, 2013
• Results First Submitted Date: September 27, 2017
• Results First Posted Date: January 3, 2018
• Last Update Posted Date: January 3, 2018
• Study Start Date: October 2012
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2017)

• 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.
• 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.

Original Primary Outcome Measures (submitted: January 30, 2013)

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bladder ARFI (Acoustic Radiation Force Impulse) Study
• Official Title: Evaluation of Pediatric Urinary Bladder Wall Thickening and Fibrosis Using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocities
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Bladder Fibrosis

Intervention

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.

Study Arms

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.

Intervention: Device: ARFI-Derived Shear Wave Velocities

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2017): 26
• Original Estimated Enrollment (submitted: January 30, 2013): 30
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01781832
• Other Study ID Numbers: HUM00064416
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ethan Smith, University of Michigan
• Study Sponsor: University of Michigan
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ethan Smith, M.D.; University of Michigan Hospital

• PRS Account: University of Michigan
• Verification Date: December 2017