NCT07159503

VISOR Versus PCNL for Treatment of 2-4cm Renal Stones

Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL). The main questions it aims to answer are: How many participants are stone-free within 24 hours after surgery? How many participants are stone-free 1 month after surgery? What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL? Does VISOR help keep kidney pressure stable during surgery? Researchers will compare VISOR to PCNL to see which treatment works better and is safer. Participants will: Be randomly assigned to have surgery with either VISOR or PCNL. Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared. Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging. About 170 people will take part in this study at cooperative hospitals.

Conditions

• Kidney Calculi
• Kidney Stones

Interventions

Type	Name	Description
PROCEDURE	Vortex Intelligence Stone Optimized Removal	Vortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications.
PROCEDURE	Percutaneous Nephrolithotomy (PCNL)	A standard PCNL technique will be performed according to institutional practice guidelines.

Timeline

• Start date: 2025-04-20
• Primary completion: 2027-02-20
• Completion: 2027-08-20
• First posted: 2025-09-08
• Last updated: 2025-09-12

Locations

1 site across 1 country: China