Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07909577
NA

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

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.