Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT01781832
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2013-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bladder ARFI (Acoustic Radiation Force Impulse) Study
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Evaluation of Pediatric Urinary Bladder Wall Thickening and Fibrosis Using Acoustic Radiation Force Impulse (ARFI)-Derived Shear Wave Velocities
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: