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Hydronephrosis ARFI Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781845
First Posted: February 1, 2013
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
  Purpose
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.

Condition Intervention
Hydronephrosis Procedure: AFRI-SVI Ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis

Resource links provided by NLM:


Further study details as provided by Jonathan R. Dillman M.D., University of Michigan:

Primary Outcome Measures:
  • ARFI-SVI [ Time Frame: 6 months ]
    fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.


Enrollment: 41
Study Start Date: November 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARFI-SVI Ultrasound
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.
Procedure: AFRI-SVI Ultrasound
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or younger
  2. You are scheduled for diuretic scintigraphy (DRS)testing -

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781845


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jonathan Dillman, M.D. University of Michigan Hospital
  More Information

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01781845     History of Changes
Other Study ID Numbers: HUM00064524
First Submitted: January 30, 2013
First Posted: February 1, 2013
Last Update Posted: June 1, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Hydronephrosis
Kidney Diseases
Urologic Diseases