Urine RefluxNCT01781819
(ARFI) Shear Velocity Imaging of the Kidneys in Pediatric Patients
A study testing ARFI SVI Ultrasound Imaging in people with Urine Reflux and Kidney Damage, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Urine Reflux, Kidney Damage
- What is being tested?
- ARFI SVI Ultrasound Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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. -
Who cannot join
- None to list
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux
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).
- Conditions
- Urine Reflux, Kidney Damage
- Being tested
- ARFI SVI Ultrasound Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARFI SVI Ultrasound ImagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ARFI SVI ultrasound imaging | Experimental | Acoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging Receives: Procedure: ARFI SVI Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine RefluxStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Dillman M.D., University of Michigan
- Investigators
- Jonathan Dillman, MD, Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781819
- Sponsor's protocol ID
- HUM00063972
- Status last verified
- May 2015
- First submitted
- 29 Jan 2013
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Based Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)of the Kidneys in Pediatric Patients With Vesicoureteral Reflux
- ClinicalTrials.gov ID
- NCT01781819
- Acronym / sponsor ID
- HUM00063972
- Conditions
- Urine Reflux, Kidney Damage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARFI SVI ultrasound imaging | Experimental | Procedure: ARFI SVI Ultrasound ImagingAcoustic Radiation Force Impulse (ARFI) Shear Wave Velocity Imaging (SVI) ultrasound imaging |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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. -
Key exclusion criteria (1 listed)
- None to list
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFI SVI Ultrasound ImagingFollowing 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. | Procedure or surgery | ARFI SVI ultrasound imaging |
Primary outcome
Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI)
Time frame: 6 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Dillman, MD principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARFI SVI Ultrasound Imaging in people with Urine Reflux and Kidney Damage, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound-Based Acoustic Radiation Force Impulse(ARFI)Shear Wave Velocity Imaging (SVI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.