Ureteral CalculiNCT02577146

The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic

A study testing renal and bladder ultrasound with ureteral jet assessment in people with Ureteral Calculi, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single institution, prospective study to evaluate the prognostic significance of renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the spontaneous stone passage rate of ureteral stones. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ureteral Calculi
What is being tested?: renal and bladder ultrasound with ureteral jet assessment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 18 and older at the time of consent
willing and able to sign consent
CT diagnosis of ureteral stone with a stone burden less than or equal to 10mm

Who cannot join

obstructed solitary kidney
obstructed transplant kidney
bilateral obstructed kidneys
any condition or reason that, in the opinion of the treating physician, interferes with the patient's ability to participate or places the patient at undue risk.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Conditions: Ureteral Calculi
Being tested: renal and bladder ultrasound with ureteral jet assessment
Keywords: stone, ureter, ultrasound
Medical subject headings: Ureteral Calculi, Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

renal and bladder ultrasound with ureteral jet assessmentDevice
The number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side.

Study groups in NCT02577146
Study group	Role	What they receive
Study ultrasound	Experimental	Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention. Receives: Device: renal and bladder ultrasound with ureteral jet assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Time in Days From Diagnosis to Stone Passage.
Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).
Measured: 42 days

Secondary outcomes (1)

The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.
Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2019

First posted16 Oct 2015 (estimated)
Study startOct 2015
Primary completion7 May 2018
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ureteral CalculiStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02577146
Sponsor's protocol ID: 201506127
Status last verified: Dec 2019
First submitted: 29 Sep 2015
Last updated: 10 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Active, not recruiting
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney Calculi, Kidney Diseases
Active, not recruitingObservational study
Stone and Laser Therapies Post-Market Study (SALT)
Benign Prostate Hypertrophy(BPH), Renal Calculi
Recruiting
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
Urolithiasis, Kidney Calculi

All Ureteral Calculi trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
ClinicalTrials.gov ID: NCT02577146
Acronym / sponsor ID: 201506127
Conditions: Ureteral Calculi
Keywords: stone, ureter, ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Midwest Stone Institute.
Study start: Oct 2015
Primary completion: 7 May 2018 (actual)
Study completion: Dec 2019 (actual)
First posted: 16 Oct 2015 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study ultrasound	Experimental	Device: renal and bladder ultrasound with ureteral jet assessmentStudy ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age 18 and older at the time of consent
willing and able to sign consent
CT diagnosis of ureteral stone with a stone burden less than or equal to 10mm

Key exclusion criteria (4 listed)

obstructed solitary kidney
obstructed transplant kidney
bilateral obstructed kidneys
any condition or reason that, in the opinion of the treating physician, interferes with the patient's ability to participate or places the patient at undue risk.

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
renal and bladder ultrasound with ureteral jet assessmentThe number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side.	Device	Study ultrasound

Primary outcome

Time in Days From Diagnosis to Stone Passage.
Time frame: 42 days
Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).

1 secondary outcome

The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.
Time frame: 42 days

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Ultrasound	74	46

Primary outcome: Time in Days From Diagnosis to Stone Passage.

Time frame: 42 days. Median (95% Confidence Interval). Unit: Days

Measure	Study Ultrasound n = 46
Present Jets	5 (3 to 13)
Absent Jets	13 (8 to NA)

Population analysed: 28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participation in the proposed study did not pose any risks to the participants beyond what was expected from the standard of care stone management. Study PI monitored the study for any adverse events from the time of the study RBUS to day 42 post diagnostic CT. The timeframe in which data for adverse events was collected for this study was up to 45 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Ultrasound	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ureteral Calculi

Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Active, not recruiting
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney Calculi, Kidney Diseases
Active, not recruitingObservational study
Stone and Laser Therapies Post-Market Study (SALT)
Benign Prostate Hypertrophy(BPH), Renal Calculi
Recruiting
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
Urolithiasis, Kidney Calculi

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.

Alana Desai, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing renal and bladder ultrasound with ureteral jet assessment in people with Ureteral Calculi, run by Washington University School of Medicine 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 3 inclusion and 4 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 10 Dec 2019. 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?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time in Days From Diagnosis to Stone Passage. (time frame: 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02577146.

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 10 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.