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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577146
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : May 31, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Midwest Stone Institute.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Ureteral Calculi Device: renal and bladder ultrasound with ureteral jet assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
Study Start Date : October 2015
Actual Primary Completion Date : May 7, 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study ultrasound
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.
Device: renal and bladder ultrasound with ureteral jet assessment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan. [ Time Frame: 42 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577146


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Midwest Stone Institute.
Investigators
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Principal Investigator: Alana Desai, M.D. Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02577146    
Other Study ID Numbers: 201506127
First Posted: October 16, 2015    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: December 10, 2019
Last Verified: December 2019
Keywords provided by Washington University School of Medicine:
stone
ureter
ultrasound
Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Calculi
Renal Colic
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Signs and Symptoms
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi