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Bladder ARFI (Acoustic Radiation Force Impulse) Study

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. Read our disclaimer for details.
 
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

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects Having Urinary Testing
Hide 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
Arm/Group Title (ARFI)-Derived Shear Wave Velocities
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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
Hide 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)
1.Primary Outcome
Title Shear Wave Velocity, VTQ
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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%) 
Hide Serious Adverse Events
(ARFI)-Derived Shear Wave Velocities
Affected / at Risk (%)
Total   0/25 (0.00%) 
Hide 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%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ethan Smith, MD
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513 636-4200
EMail: Ethan.Smith@cchmc.org
Layout table for additonal information
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