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Enrolling by Invitation

NCT Number: NCT07159503

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

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 230000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vortex Intelligence Stone Optimized Removal

Procedure

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)

Procedure

A standard PCNL technique will be performed according to institutional practice guidelines.

Primary outcomes

  1. Stone-free rate within 24 hours

    Time frame: 24 hours after surgery

    The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.

Secondary outcomes

  1. Stone-free rate at 1 month

    Time frame: 28 ± 7 days after surgery

    The percentage of participants whose stones are completely cleared at 1 month after surgery, evaluated using CT or ultrasound.

  2. Operative Time

    Time frame: During surgery (Day 0)

    Total time from the beginning to the end of the surgery, measured in minutes.

  3. Postoperative fever

    Time frame: 0-30 days after surgery

    Incidence of participants experiencing a body temperature ≥38°C within 30 days after surgery.

  4. Postoperative ureteral stricture

    Time frame: 28 ± 7 days after surgery

    Occurrence of ureteral narrowing detected by imaging within 1 month after surgery.

  5. Pain assessment (VAS score)

    Time frame: Postoperative Day 0-28

    Participants report their pain using the Visual Analog Scale (VAS) at different time points postoperatively.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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