Clinical trial Recruiting at 1 site Interventional Ages 0 to 14

Comparing two types of flexible ureteroscopes for treating kidney stones in children

Official title: Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children: A Single-center Randomized Controlled Trial

Run by The Children's Hospital of Zhejiang University School of Medicine · NCT06628765 · Data updated 2026-11-12

This study is testing two different sizes of flexible tools used to remove kidney stones in kids to see which one works better and is safer.

More Urinary Stone trials

Quick facts

Study typeInterventional
Ages0 Years to 14 Years
SexAll
Enrollment52 (estimated)
SponsorThe Children's Hospital of Zhejiang University School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedOctober 8, 2024
Main results expectedApril 8, 2025
Study endsApril 8, 2025
Registry record updatedNovember 12, 2024
Trial IDNCT06628765 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children under 14 years old with kidney stones sized between 5 mm and 20 mm.

Probably not a fit

Patients with uncontrolled urinary tract infections, severe renal insufficiency, or significant comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the safety and efficacy of two different sizes of single-use flexible ureteroscopes (fURS) for treating upper urinary tract stones in children. The two sizes being evaluated are 6.3 Fr and 8.6 Fr, with a focus on how their outer diameters affect treatment outcomes. The study will involve children under 14 years old who are scheduled for ureteroscopy and laser lithotripsy for kidney stones. By determining the equivalence of these two devices, the research seeks to improve surgical options and outcomes for pediatric patients with urinary stones.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for children suffering from urinary stones.

How similar studies have gone: While this approach is innovative, similar studies have shown promising results with flexible ureteroscopes in adult populations, but this specific comparison in children is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm)
* Patients \< 14 years
* For children younger than 8 years old, the informed consent form is signed by the parents; for children older than 8 years old, the informed consent form is signed by both the parents and the child themselves.

Exclusion Criteria:

* Children with uncontrolled urinary tract infections or coagulation disorders and other contraindications for surgery before the operation.
* Children with severe renal insufficiency, anatomical or functional solitary kidney, known nephrocalcinosis, and other significant comorbidities that are not suitable for participating in the study.
* Children who refuse to participate in this study.
* Any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.

Where it's running

  • Children's hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

  • Principal investigator: Hongbo Liu — The Children's Hospital of Zhejiang University School of Medicine
  • Study coordinator: Aimei Ma
  • Email: maaimei@zju.edu.cn
  • Phone: +86 15888864134

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.