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.
Percutaneous Nephrolithotomy (PCNL): A standard PCNL technique will be performed according to institutional practice guidelines.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07159503 on ClinicalTrials.gov ↗ ← All trials in China