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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02577146
Other study ID # 201506127
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date December 2019

Study information

Verified date December 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date December 2019
Est. primary completion date May 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine Midwest Stone Institute.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 42 days
Secondary The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan. 42 days
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