NCT05416502

Brief Summary

Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

November 16, 2021

Last Update Submit

June 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Passage

    The number of recruited individuals whose ureteral stones are found to be passed by their report and it is confirmed by ultrasound

    3 months

Study Arms (2)

Passage Observed

Enrolled patients whose stone and ureter diameters are obtained and their stone passage was successful during the follow-up.

Procedure: Ultrasound

Passage Not Observed

Enrolled patients whose stone and ureter diameters are obtained and their stone passage was not successful during the follow-up.

Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

Enrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder.

Passage Not ObservedPassage Observed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ureter stones

You may qualify if:

  • Ureteral Stone smaller than 1 cm Volunteer to be enrolled

You may not qualify if:

  • Pyonephrosis Urinary Sepsis Untraceable Pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ureterolithiasis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Ozer U Cakici, MD, FEBU

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

June 13, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

IPD will be shared among the following criteria: * As allowed to the degree which is allowed by the enrolled patients. * As required by the researchers

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations