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WithdrawnNCT01781819Updated Jun 1, 2015

(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients

An interventional study of ARFI SVI Ultrasound Imaging in Urine Reflux and Kidney Damage, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2015-06-01.

Sponsored by University of Michigan · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
PI leaving institution
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Urine Reflux
  • Kidney Damage
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 years of age and younger
  2. Are scheduled to have a clinically ordered kidney ultrasound and a voiding cystourethrogram (to evaluate urine reflux) on the same day. -

Exclusion criteria

Exclusion Criteria:

None to list

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    ARFI SVI ultrasound imaging

    Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging

    Procedure: ARFI SVI Ultrasound Imaging

Interventions

  • ProcedureARFI 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.

06

What researchers measure

Primary outcomes

  1. Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI)

    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

    Time frame: 6 months

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01781819
Lead sponsor
University of Michigan
Responsible party
Jonathan R. Dillman M.D. (Principal Investigator, University of Michigan) — Principal investigator
First posted
Feb 1, 2013
Start date
Oct 2012
Primary completion
Nov 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jun 1, 2015

Study contacts

Jonathan Dillman, MD
principal investigator · University of Michigan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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