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Hydronephrosis ARFI Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01781845
First received: January 30, 2013
Last updated: May 29, 2015
Last verified: May 2015

January 30, 2013
May 29, 2015
November 2012
May 2015   (final data collection date for primary outcome measure)
ARFI-SVI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.
Same as current
Complete list of historical versions of study NCT01781845 on ClinicalTrials.gov Archive Site
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Hydronephrosis ARFI Study
Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis
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.
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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hydronephrosis
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.
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.
Intervention: Procedure: AFRI-SVI Ultrasound
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Both
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01781845
HUM00064524
Yes
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Jonathan R. Dillman M.D., University of Michigan
University of Michigan
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Principal Investigator: Jonathan Dillman, M.D. University of Michigan Hospital
University of Michigan
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP