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Clinical Trials in China / NCT07159503
Enrolling by invitation Not applicable

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

NCT07159503 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-04-20
Last updated
2025-09-12

Condition(s) studied

Kidney CalculiKidney Stones

Investigational drug(s) / intervention(s)

Vortex Intelligence Stone Optimized RemovalPercutaneous Nephrolithotomy (PCNL)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm * Age between 18 and 80 years, regardless of gender * Mentally sound and able to comprehend study details and provide informed consent Exclusion Criteria: * Presence of ureteral stricture or history thereof * Previous open or laparoscopic renal and/or ureteral surgery * Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery * Pregnancy, lactation, or menstruation at the time of surgery * ASA classification \> Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery * Renal anatomical anomalies such as polycystic kidney, horseshoe kidney, or ectopic kidney * Coagulation dysfunction (e.g., INR \> 1.5 or platelet count \< 80 × 10⁹/L) * Intraoperative failure to successfully place the ureteral access sheath

Primary outcome measure(s)

  • Stone-free rate within 24 hours — 24 hours after surgery
    The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.

Trial sites (1)

FacilityCityRegionStatus
2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

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Other trials for the same condition

FANS-Assisted Mini-PCNL for Complex Renal Stones Active, not recruiting
An International Multicenter Clinical Study on Application of UroMed AI Doctor Based on Large Language Models Starting soon
Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial Recruiting
Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones Recruiting
Effect of Negative Pressure Suction on Fluid Absorption and Infection in Flexible Ureteroscopy Recruiting
Official registry record

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