HydronephrosisNCT01781845
Hydronephrosis ARFI Study
A study testing AFRI-SVI Ultrasound in people with Hydronephrosis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hydronephrosis
- What is being tested?
- AFRI-SVI Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2015
- 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 or younger
- You are scheduled for diuretic scintigraphy (DRS)testing -
Who cannot join
- None
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- Conditions
- Hydronephrosis
- Being tested
- AFRI-SVI Ultrasound
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFRI-SVI UltrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ARFI-SVI Ultrasound | Experimental | 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. Receives: Procedure: AFRI-SVI Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARFI-SVI
fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology.
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 startNov 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies 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
- 41 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, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781845
- Sponsor's protocol ID
- HUM00064524
- Status last verified
- May 2015
- First submitted
- 30 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
- Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis
- ClinicalTrials.gov ID
- NCT01781845
- Acronym / sponsor ID
- HUM00064524
- Conditions
- Hydronephrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- 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.
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.
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 | Experimental | Procedure: AFRI-SVI UltrasoundUltrasound 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. |
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 or younger
- You are scheduled for diuretic scintigraphy (DRS)testing -
Key exclusion criteria (2 listed)
- None
- -
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 |
|---|---|---|
| AFRI-SVI UltrasoundThis 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. | Procedure or surgery | ARFI-SVI Ultrasound |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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, M.D. 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 AFRI-SVI Ultrasound in people with Hydronephrosis, 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 2 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ARFI-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.