(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients
This study is currently recruiting participants.
Verified January 2013 by University of Michigan
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01781819
First received: January 29, 2013
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
Urine reflux (urine backing up into the kidneys) is common in the pediatric population and may be complicated by renal abnormalities, such as infection and scarring. Currently, urine reflux is detected using either voiding cystourethrogram or other procedures. A new technique called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity imaging SVI) is performed using standard approved ultrasound machines and transducers bu the sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into the kidneys).
| Condition | Intervention |
|---|---|
|
Urine Reflux Kidney Damage |
Procedure: ARFI SVI Ultrasound Imaging |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To determine if this new ultrasound based imaging will effectively measure shear wave velocity in kidneys affected by urine reflux and be useful in determining the extent of kidney damage
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ARFI SVI ultrasound imaging
Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging
|
Procedure: ARFI SVI Ultrasound Imaging
Following a clinical renal ultrasound scan, the research scan using the ultrasound based acoustic radiation force impulse, or shear wave velocity imaging will be performed using standard approved ultrasound machines and transducers. This imaging will take approximately 5 to 10 minutes to complete.
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age and younger
- Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. -
Exclusion Criteria:
None to list
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781819
Contacts
| Contact: Jonathan Dillman, MD | (734)232-9247 | |
| Contact: James Pool, CCRC | (734)615-7391 | jampool@umich.edu |
Locations
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Jonathan Dillman, M.D. 734-232-9247 | |
| Contact: James Pool Jr., CCRC 734-615-7391 jampool@umich.edu | |
Sponsors and Collaborators
University of Michigan
Investigators
| Principal Investigator: | Jonathan Dillman, MD | University of Michigan Hospital |
More Information
No publications provided
| Responsible Party: | Jonathan R. Dillman M.D., Principal Investigator, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01781819 History of Changes |
| Other Study ID Numbers: | HUM00063972 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Vesico-Ureteral Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013