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

Primary Purpose

Ureteral Calculi

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
renal and bladder ultrasound with ureteral jet assessment
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ureteral Calculi focused on measuring stone, ureter, ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study ultrasound

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2015
Last Updated
December 6, 2019
Sponsor
Washington University School of Medicine
Collaborators
Midwest Stone Institute.
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1. Study Identification

Unique Protocol Identification Number
NCT02577146
Brief Title
The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
Official Title
The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Midwest Stone Institute.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi
Keywords
stone, ureter, ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
renal and bladder ultrasound with ureteral jet assessment
Intervention Description
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 Measure Information:
Title
Time in Days From Diagnosis to Stone Passage.
Description
Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).
Time Frame
42 days
Secondary Outcome Measure Information:
Title
The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Desai, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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