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;
Parallel
VISOR
Procedure/SurgerySurgery will be performed using the VISOR through a 14Fr UAS
fURS
Procedure/SurgerySurgery will be performed using a standard single-use electronic ureterorenoscope through a 14Fr UAS
Immediate Postoperative Stone-Free Rate (SFR):
Stone clearance rate within 24 hours after surgery.
Stone-Free Rate at 3 Months Postoperatively
Stone-Free Rate at 3 Months Postoperatively
Ureteroscopy Operation Time:
Duration from the insertion of the flexible ureteroscope to its removal.
Lithotripsy Time
Time spent on lithotripsy
Total Laser Energy
Total laser energy delivered (in joules)
Traxer Ureteral Injury Grading
Grade 0: No injury or only mucosal bleeding. Grade 1: Ureteral mucosal injury without involvement of the smooth muscle layer. Grade 2: Ureteral wall injury involving the mucosa and smooth muscle layers, without penetration of the adventitia (no visible fat tissue). Grade 3: Ureteral wall injury involving the mucosa and smooth muscle layers, with penetration of the adventitia (fat tissue visible). Grade 4: Complete ureteral tear.
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