Trial Outcomes & Findings for Bladder ARFI (Acoustic Radiation Force Impulse) Study (NCT NCT01781832)
NCT ID: NCT01781832
Last Updated: 2018-01-03
Results Overview
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.
COMPLETED
NA
26 participants
Visit 0
2018-01-03
Participant Flow
Participant milestones
| Measure |
Subjects Having Urinary Testing
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.
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|---|---|
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Subjects Having Urinary Testing
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Bladder ARFI (Acoustic Radiation Force Impulse) Study
Baseline characteristics by cohort
| Measure |
(ARFI)-Derived Shear Wave Velocities
n=26 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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26 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
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Sex: Female, Male
Female
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11 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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15 Participants
n=99 Participants
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Region of Enrollment
United States
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26 Participants
n=99 Participants
|
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Age
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4.6 years
n=99 Participants
|
PRIMARY outcome
Timeframe: Visit 0Population: 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.
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.
Outcome measures
| Measure |
(ARFI)-Derived Shear Wave Velocities
n=25 Participants
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.
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|---|---|
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Shear Wave Velocity, VTQ
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1.95 meters per second
Standard Deviation 0.63
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PRIMARY outcome
Timeframe: Visit 0Population: 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.
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.
Outcome measures
| Measure |
(ARFI)-Derived Shear Wave Velocities
n=25 Participants
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.
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|---|---|
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Shear Wave Velocity (VITQ)
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2.37 meters per second
Standard Deviation 0.51
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Adverse Events
(ARFI)-Derived Shear Wave Velocities
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ethan Smith, MD
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place