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NOT YET RECRUITING
NCT06841523
NA

An Intelligent Pressure and Temperature Control Ureteral Soft Scope System for Treating Stones With Infection.

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine the efficacy and safety of a novel intelligent pressure and temperature-controlled ureteroscope system for treating renal and upper ureteral stones with concurrent infection. It will also assess its ability to reduce postoperative complications and improve stone clearance rates. The main questions it aims to answer are: Does the intelligent system lower the complication rate and enhance stone clearance compared to standard ureteroscopy? What safety issues or medical problems do participants experience when using the intelligent system? Researchers will compare the intelligent pressure and temperature-controlled ureteroscope system to a standard ureteroscope to evaluate its effectiveness in treating renal and upper ureteral stones. Participants will: Undergo surgery using either the intelligent system or a standard ureteroscope Be monitored for postoperative complications, stone clearance, and other relevant outcomes Participate in follow-up visits to assess recovery and treatment efficacy

Official title: Intelligent Pressure and Temperature Control Ureteral Soft Scope System for the Treatment of Upper Ureteral Stones Complicated With Infection in the Kidney and Upper Ureter: a Multicenter Randomized Controlled Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2025-04-01

Completion Date

2028-04-01

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

DEVICE

Intelligent Pressure and Temperature-Controlled Ureteroscope System

RIRS procedure for upper ureteral or renal stone lithotripsy with Intelligent Pressure and Temperature-Controlled Ureteroscope System

DEVICE

Conventional Ureteroscope

RIRS procedure for upper ureteral or renal stone lithotripsy with conventional ureteroscope

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China