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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
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.
A standard PCNL technique will be performed according to institutional practice guidelines.
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Stone-free rate within 24 hours
The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.
Time frame: 24 hours after surgery
Stone-free rate at 1 month
The percentage of participants whose stones are completely cleared at 1 month after surgery, evaluated using CT or ultrasound.
Time frame: 28 ± 7 days after surgery
Operative Time
Total time from the beginning to the end of the surgery, measured in minutes.
Time frame: During surgery (Day 0)
Postoperative fever
Incidence of participants experiencing a body temperature ≥38°C within 30 days after surgery.
Time frame: 0-30 days after surgery
Postoperative ureteral stricture
Occurrence of ureteral narrowing detected by imaging within 1 month after surgery.
Time frame: 28 ± 7 days after surgery
Pain assessment (VAS score)
Participants report their pain using the Visual Analog Scale (VAS) at different time points postoperatively.
Time frame: Postoperative Day 0-28
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