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Enrolling by invitation NCT07159503

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

No phase Interventional Kidney Calculi Kidney Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vortex Intelligence Stone Optimized Removal, Percutaneous Nephrolithotomy (PCNL).
Who it may be relevant to
Registry conditions: Kidney Calculi, Kidney Stones. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones

Overview

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.

Interventions

  • Procedure 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.
  • Procedure Percutaneous Nephrolithotomy (PCNL)
    A standard PCNL technique will be performed according to institutional practice guidelines.

Primary outcome measures

  • Stone-free rate within 24 hours [Time frame: 24 hours after surgery]
Secondary outcome measures (5)
  • Stone-free rate at 1 month [Time frame: 28 ± 7 days after surgery]
  • Operative Time [Time frame: During surgery (Day 0)]
  • Postoperative fever [Time frame: 0-30 days after surgery]
  • Postoperative ureteral stricture [Time frame: 28 ± 7 days after surgery]
  • Pain assessment (VAS score) [Time frame: Postoperative Day 0-28]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT07159503 · 2025-134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗