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

• Study Type: Interventional
• 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
• Enrollment: 26

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Subjects Having Urinary Testing
Arm/Group Description	Subjects were pediatric patients scheduled to have a test on their bladder called CMG (cystometrogram). CMG is an invasive test that requires insertion of a catheter (tube) into the bladder. The patients agreed to have a research ultrasound (US) of their bladder. The US included a technique called elastography, which uses sound waves to measure the stiffness of tissue.
Period Title: Overall Study
Started	26
Completed	25
Not Completed	1
Reason Not Completed
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		(ARFI)-Derived Shear Wave Velocities
Arm/Group Description		This is an new ultrasound-based technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. ARFI can be used to aid in detecting wall thickness and fibrosis in the urinary bladder of pediatric patients. ARFI-Derived Shear Wave Velocities: This technology uses ultrasound scanning with acoustic radiation force impulse-derived (called ARFI). This technique measures shear wave velocities to obtain and analyze images of the urinary bladder. The research ultrasound scan takes 10-15 minutes to complete.
Overall Number of Baseline Participants		26
Baseline Analysis Population Description		26 subjects were included in this study.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	<=18 years	26 100.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	Female	11 42.3%
	Male	15 57.7%
Region of Enrollment [1]; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	26 participants
		26 100.0%
		[1] Measure Description: The study location was a large tertiary pediatric hospital in the Midwest of the United States.
Age; Mean (Full Range); Unit of measure: Years
	Number Analyzed	26 participants
		4.6; (1 to 15)

Outcome Measures

1. Primary Outcome

Title	Shear Wave Velocity, VTQ
Description	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.
Time Frame	Visit 0

Outcome Measure Data

Analysis Population Description

The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the urinary bladder.

The ultrasound scans were investigated as an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure.

Arm/Group Title	(ARFI)-Derived Shear Wave Velocities
Arm/Group Description:	This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients. ARFI-Derived Shear Wave Velocities: An ultrasound scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan l takes 15 minutes to complete. The shear wave velocity is a measure of the stiffness of the bladder wall.
Overall Number of Participants Analyzed	25
Mean (Standard Deviation); Unit of Measure: meters per second
	1.95 (0.63)

2. Primary Outcome

Title	Shear Wave Velocity (VITQ)
Description	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.
Time Frame	Visit 0

Outcome Measure Data

Analysis Population Description

The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the bladder. The ultrasound scans may be an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure.

Arm/Group Title	(ARFI)-Derived Shear Wave Velocities
Arm/Group Description:	This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients. ARFI-Derived Shear Wave Velocities: An ultrasound scan using acoustic radiation force impulse-derived shear wave velocities to obtain images of the urinary bladder. The research ultrasound scan l takes 15 minutes to complete. The shear wave velocity is a measure of the stiffness of the bladder wall.
Overall Number of Participants Analyzed	25
Mean (Standard Deviation); Unit of Measure: meters per second
	2.37 (0.51)

Adverse Events

Time Frame	Subjects were observed for any adverse event at their sole visit.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	(ARFI)-Derived Shear Wave Velocities
Arm/Group Description	This is an ultrasound-based new technique using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocity Imaging. This will aid in detecting bladder wall thickness and fibrosis in the urinary bladder of pediatric patients. 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.
All-Cause Mortality
	(ARFI)-Derived Shear Wave Velocities
	Affected / at Risk (%)
Total	0/25 (0.00%)
Serious Adverse Events
	(ARFI)-Derived Shear Wave Velocities
	Affected / at Risk (%)
Total	0/25 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	(ARFI)-Derived Shear Wave Velocities
	Affected / at Risk (%)
Total	0/25 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Ethan Smith, MD
• Organization: Cincinnati Children's Hospital Medical Center
• Phone: 513 636-4200
• EMail: Ethan.Smith@cchmc.org

• Responsible Party: Ethan Smith, University of Michigan
• ClinicalTrials.gov Identifier: NCT01781832
• Other Study ID Numbers: HUM00064416
• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Results First Submitted: September 27, 2017
• Results First Posted: January 3, 2018
• Last Update Posted: January 3, 2018