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.
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
About this study
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Stone Institute.
- Responsible party
- Sponsor
- Investigators
- Alana Desai, M.D., Principal investigator, Washington University School of Medicine
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
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.
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.
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
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
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingObservational study
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
Kidney Calculi, Nephrolithiasis
Not yet recruiting
Ureteral Access Strategies in Retrograde Intrarenal Surgery
Nephrolithiasis, Kidney Calculi
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
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?
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.