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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
This prospective, multicenter, randomized, non-inferiority controlled trial aims to compare the efficacy and safety of smart pressure-controlled flexible ureteroscopy and flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath in patients with 2-3 cm renal stones. Eligible patients will be randomly assigned to one of the two treatment groups. The primary objective is to determine whether smart pressure-controlled flexible ureteroscopy is non-inferior to the suction sheath-assisted approach in terms of stone-free rate. Secondary outcomes include operative time, postoperative complications, intrarenal pressure-related outcomes, length of hospital stay, and other relevant perioperative parameters. The findings are expected to provide clinical evidence to guide the selection of surgical techniques for patients with 2-3 cm renal stones.
Official title: A Prospective, Multicenter, Randomized, Non-Inferiority Controlled Trial Comparing the Efficacy and Safety of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Ureteroscopy Assisted by a Distal Flexible Suction Ureteral Access Sheath for the Treatment of 2-3 cm Renal Stones
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2026-11-01
Completion Date
2027-11-01
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Smart Pressure-Controlled Flexible Ureteroscopy
Flexible ureteroscopy for the treatment of 2-3 cm renal stones using a smart pressure-control system to regulate intrarenal pressure during lithotripsy. The procedure will be performed according to the study protocol and the device instructions for use.
Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy
Flexible ureteroscopy for the treatment of 2-3 cm renal stones using a distal flexible suction ureteral access sheath to facilitate stone fragment evacuation and urinary drainage during lithotripsy. The procedure will be performed according to the study protocol and the device instructions for use.