This prospective randomized controlled clinical study aims to evaluate the safety and efficacy of a novel Vortex Intelligence Stone Optimized Removal (VISOR,The experimental group) system compared to a single-use ureterorenoscope (the control) for treating upper urinary tract stones.
A total of 100 patients with upper urinary tract stones (cumulative stone diameter ≤3 cm) will be enrolled and randomly assigned in a 1:1 ratio to either the experimental group (n=50) or the control group (n=50). The experimental group will undergo surgery using the innovative system, which integrates irrigation-suction, pressure monitoring-regulation, and lithotripsy-evacuation functions. The control group will be treated with a conventional single-use ureterorenoscope.
The primary outcome measure is the immediate stone-free rate (SFR), defined as the proportion of patients with residual fragments \<4 mm on renal non-contrast computed tomography (NCCT) performed within 24 hours postoperatively. Key secondary endpoints include the SFR at 3 months, operative and lithotripsy times, total laser energy used, intraoperative ureteral injury (Traxer grading), postoperative pain scores, incidence of fever (\>38.0°C), and overall complication rates (Clavien-Dindo classification).
Patient follow-up assessments will be conducted at 24 hours, 21±7 days, and 90±14 days post-surgery to monitor stone clearance, complications, and recovery. This study seeks to determine if the novel system offers superior stone clearance while maintaining a safe renal pelvic pressure profile, potentially improving outcomes for patients with larger renal stones treated ureteroscopically.
Patients with upper urinary tract stones and a cumulative stone diameter ≤3 cm;
Patients scheduled to undergo "flexible ureteroscopic holmium laser lithotripsy";
Age ≥18 years;
Patients without psychiatric disorders or language dysfunction, capable of understanding the study and providing informed consent.
Patients requiring bilateral lithotripsy in a single-stage ureteroscopic procedure;
Ipsilateral hydronephrosis with >4 cm renal pelvic separation;
Patients with a history of open or laparoscopic renal and/or ureteral surgery;
Fever (body temperature ≥38°C) due to urinary tract infection or other causes within one week prior to surgery;