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RECRUITING
NCT06628765
NA

Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

View on ClinicalTrials.gov

Summary

The single-use digital flexible Ureteroscopy (fURS) is commonly used for the treatment of upper urinary tract stones. The size of the outer diameter of the fURS can affect the safety, efficacy, and medical costs of the treatment. Particularly for children, their ureters are thinner and more tortuous compared to adults, which places higher demands on medical devices. The investigators are interested in determining if the performance of the two different sizes of fURS (6.3 Fr vs. 8.6 Fr) are equivalent. This study will have guiding significance for the selection of upper urinary tract stones surgery in children in the future.

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

Key Details

Gender

All

Age Range

0 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-10-08

Completion Date

2025-04-08

Last Updated

2024-11-12

Healthy Volunteers

No

Conditions

Interventions

DEVICE

8.6 Fr single-use fURS (XFGC-FU-660RC)

Comparative device

DEVICE

6.3 Fr single-use fURS (Hugemed, HU30S)

Device being tested

Locations (1)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China