Study Comparing Two Sizes of Single-Use Flexible Ureteroscopes for Treating Upper Urinary Tract Stones in Children A Randomized Trial at a Single Center

What this Trial Is About

This research aims to compare the safety and effectiveness of two sizes of single-use digital flexible ureteroscopes fURS for treating upper urinary tract stones in children. Because childrens ureters are narrower and more curved than adults, the size of the fURS can impact the success and cost of the procedure. The study evaluates whether the smaller 6.3 Fr fURS performs as well as the standard 8.6 Fr fURS, aiming to guide future surgical choices for pediatric urinary stones. The study involves two groups one treated with the 8.6 Fr single-use fURS XFGC-FU-660RC and the other with the 6.3 Fr single-use fURS HugeMed, HU30S. These devices are sterile, disposable, and designed for flexible endoscopy. The smaller 6.3 Fr fURS is the thinnest of its kind and may reduce the need for ureter dilation or stenting during surgery, potentially lowering risks and costs. Each child will receive one of the two devices during ureteroscopy and laser lithotripsy to remove kidney stones. Participants will be monitored during the procedure for the success rate of the first ureteroscope insertion, the need for ureter dilation or stents, surgery duration, and blood loss. Follow-up includes catheter duration for three days, hospital stay up to one week, and complications tracked for two months. Stone clearance will be checked four weeks after surgery. The trial starts in October 2024 and continues until April 2025, with children under 14 years old eligible to participate.

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