Back to resultsHydronephrosis ARFI Study
Primary Purpose
Hydronephrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AFRI-SVI Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Hydronephrosis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or younger
- You are scheduled for diuretic scintigraphy (DRS)testing -
Exclusion Criteria:
None
-
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARFI-SVI Ultrasound
Arm Description
Ultrasound scan using acoustic radiation force impulse-shear wave velocity imaging in the characterization of pediatric hydronephrosis. This is a non-invasive scan that uses sound waves to create the images.
Outcomes
Primary Outcome Measures
ARFI-SVI
fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01781845
Brief Title
Hydronephrosis ARFI Study
Official Title
Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as the reference standard.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydronephrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARFI-SVI Ultrasound
Arm Type
Experimental
Arm Description
Ultrasound scan using acoustic radiation force impulse-shear wave velocity imaging in the characterization of pediatric hydronephrosis. This is a non-invasive scan that uses sound waves to create the images.
Intervention Type
Procedure
Intervention Name(s)
AFRI-SVI Ultrasound
Intervention Description
This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI)a new ultrasound technology in which unique sound waves create the images/pictures of the kidney beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.
Primary Outcome Measure Information:
Title
ARFI-SVI
Description
fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or younger
You are scheduled for diuretic scintigraphy (DRS)testing -
Exclusion Criteria:
None
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Dillman, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hydronephrosis ARFI Study
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