Comparing two types of flexible ureteroscopes for treating kidney stones in children
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children: A Single-center Randomized Controlled Trial
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 0 Years to 14 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06628765 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 14 years old with kidney stones sized between 5 mm and 20 mm.
Not a fit: Patients with uncontrolled urinary tract infections, severe renal insufficiency, or significant comorbidities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.