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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (ARFI)-Derived Shear Wave Velocities | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shear Wave Velocity, VTQ | 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. | Visit 0 |
| Shear Wave Velocity (VITQ) | 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. | Visit 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Smith, M.D. | University of Michigan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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26 subjects were included in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | (ARFI)-Derived Shear Wave Velocities | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shear Wave Velocity, VTQ | 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. | 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. | Posted | Mean | Standard Deviation | meters per second | Visit 0 |
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Subjects were observed for any adverse event at their sole visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (ARFI)-Derived Shear Wave Velocities | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ethan Smith, MD | Cincinnati Children's Hospital Medical Center | 513 636-4200 | Ethan.Smith@cchmc.org |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | The study location was a large tertiary pediatric hospital in the Midwest of the United States. | Count of Participants | Participants |
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| Age | Mean | Full Range | years |
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| Primary | Shear Wave Velocity (VITQ) | 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. | 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. | Posted | Mean | Standard Deviation | meters per second | Visit 0 |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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