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

NCT07159503 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-09-12

No results posted yet for this 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.

Conditions

  • Kidney Calculi
  • Kidney Stones

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Bohan Wang, MD., Ph.D · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2027-02-20
Completion
2027-08-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159503 on ClinicalTrials.gov