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

Zhejiang University

Status: Invitation-only

Conditions: Kidney Stones; Kidney Calculi

Treatments: Procedure: Percutaneous Nephrolithotomy (PCNL); Procedure: Vortex Intelligence Stone Optimized Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT07159503

2025-134

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Experimental: VISOR

Experimental group

Description:

Participants will undergo Vortex Intelligence Stone Optimized Removal.

Treatment:

Procedure: Vortex Intelligence Stone Optimized Removal

PCNL Group

Active Comparator group

Description:

Participants undergo standard percutaneous nephrolithotomy (PCNL) for renal stone removal.

Treatment:

Procedure: Percutaneous Nephrolithotomy (PCNL)