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CompletedNCT01781845Updated Jun 1, 2015

Hydronephrosis ARFI Study

An interventional study of AFRI-SVI Ultrasound in Hydronephrosis, sponsored by University of Michigan. Completed 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

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Hydronephrosis

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03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

This study's enrollment of 41 is below the median of 100 across 23 interventional studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

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

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

None

-

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Study design

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

Study arms

  • 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

Interventions

  • ProcedureAFRI-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.

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What researchers measure

Primary outcomes

  1. ARFI-SVI

    fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.

    Time frame: 6 months

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Study locations

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

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2013
First posted
Feb 1, 2013
Start
Nov 2012
Primary completionActual
May 2015
CompletionActual
May 2015
Last update
Jun 1, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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 ↗
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Registry details

Key details

Study ID
NCT01781845
Responsible party
Jonathan R. Dillman M.D. (Principal Investigator, University of Michigan) — Principal investigator
First posted
Feb 1, 2013
Start date
Nov 2012
Primary completion
May 2015
Completion
May 2015
Last update
Jun 1, 2015

Study contacts

Jonathan Dillman, M.D.
principal investigator · University of Michigan Hospital

Oversight

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

Not currently enrolling

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

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Discussion

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