MedDataX Logo

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

NCT ID: NCT02577146

Last Updated: 2019-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteral Calculi

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stone ureter ultrasound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

renal and bladder ultrasound with ureteral jet assessment

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Midwest Stone Institute.

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alana Desai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201506127

Identifier Type: -

Identifier Source: org_study_id