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Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Start Date
April 20, 2025
Primary Completion Date
February 20, 2027
Completion Date
August 20, 2027
Last Updated
September 12, 2025
170
ESTIMATED participants
Vortex Intelligence Stone Optimized Removal
PROCEDURE
Percutaneous Nephrolithotomy (PCNL)
PROCEDURE
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Data Source & Attribution
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