NCT07559721

Brief Summary

This is a single-center, observational study including a retrospective cohort and a prospective validation cohort. The study aims to identify independent risk factors for inflammatory ureteral polyps in patients with ureteral calculi and develop a preoperative predictive model. The retrospective part will analyze clinical and imaging data of patients treated at the First Hospital of Jilin University between 2018 and 2025. The prospective part is currently recruiting participants to validate the model. The primary outcome is the intraoperative diagnosis of inflammatory ureteral polyps.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraoperative diagnosis of inflammatory ureteral polyps

    The primary outcome is the presence or absence of inflammatory ureteral polyps confirmed by intraoperative pathology or direct visualization during ureteroscopy.

    At the time of ureteroscopic surgery

Study Arms (2)

Retrospective Cohort

This cohort includes patients with ureteral calculi who underwent treatment between 2018 and 2025 at the First Hospital of Jilin University. Clinical and imaging data will be analyzed to identify risk factors for inflammatory ureteral polyps.

Prospective Validation Cohort

This prospective cohort is currently recruiting patients with ureteral calculi to validate the predictive model developed from the retrospective data.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes adult patients with ureteral calculi who underwent ureteroscopic treatment at the First Hospital of Jilin University. The retrospective cohort includes patients treated between 2018 and 2025, and the prospective cohort is recruiting new patients for validation.

You may qualify if:

  • Patients aged 18 years or older undergoing ureteroscopic surgery for ureteral calculi at the First Hospital of Jilin University.
  • Complete clinical and imaging data available.

You may not qualify if:

  • Patients with bilateral ureteral calculi.
  • Patients with preoperative nephrostomy or indwelling ureteral stent.
  • Patients with a history of ureteral or bladder cancer.
  • Patients with congenital ureteral anomalies or previous ureteral surgery.
  • Patients with severe coagulation disorders or contraindications to ureteroscopy.
  • Patients unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Ureteral Calculi

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

April 30, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations