Evaluation of the vortex intelligent stone optimized removal (VISOR) system: A first-in-human pilot study
Wenjun Gao, Vineet Gauhar, Li Fang, Jie Gu, Jia-Lun Kwok, Bhaskar K Somani, Yue Cheng, Steffi Kar Kei Yuen, Bohan WangBackground
Despite advancements in suction-assisted flexible ureteroscopy (FURS), Flexible and Navigable Ureteral Access Sheaths (FANS) and Direct-in-scope suction (DISS) techniques face technical hurdles for efficient stone evacuation. The Vortex Intelligent Stone Optimized Removal (VISOR) all-in-one system integrates automatic irrigation-suction and real-time intrarenal pressure (IRP) monitoring. It utilizes a patented reusable 12 Fr flexible ureteroscope featuring a unique dual-channel design, facilitating simultaneous irrigation-aspiration and novel vortex-assisted lithotripsy.
Objectives
To evaluate the feasibility, safety and preliminary efficacy of the VISOR system for the treatment of upper urinary tract stones in a first-in-human pilot study.
Design
Prospective, single-arm, single-center, first-in-human pilot study.
Methods
Twenty patients with upper urinary tract stones (median maximum diameter 20 mm; median stone volume 1666 mm 3 ) underwent VISOR system between July and September 2025. The primary outcome was the 24-hour stone-free rate (SFR; residual fragment ≤2 mm) by low-dose non-contrast computed tomography. Secondary outcomes included stone clearance rate, 4-week SFR, operative time, IRP control, laser efficacy, complications (Clavien-Dindo system), and Wisconsin Stone Quality of Life (WISQOL) score.
Results
The 24-hour and 4-week SFR were both 90% (18/20; 95% CI: 68.3%–98.8%). Median operative time was 29 minutes (IQR: 24–36), median IRP was 20 mmHg (IQR: 18–21), and median laser efficacy was 50 mm 3 /min (IQR: 25–75). WISQOL score improved by a median of 20 points. No Clavien-Dindo Grade I–IV complications occurred.
Conclusion
This first-in-human pilot study provides preliminary evidence supporting the feasibility and safety of the VISOR system in selected patients with upper urinary tract stones. The system consolidates pressure monitoring, automated suction, and vortex-assisted lithotripsy into a single platform, which may simplify surgical workflow. While results are promising, larger randomized controlled trials are necessary to validate these preliminary findings.