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

NCT07159503 | Enrolling By Invitation

• 1 other identifier: 2025-134
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stone-free rate within 24 hours

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

  24 hours after surgery

Secondary Outcomes (5)

• Stone-free rate at 1 month

  28 ± 7 days after surgery

• Operative Time

  During surgery (Day 0)

• Postoperative fever

  0-30 days after surgery

• Postoperative ureteral stricture

  28 ± 7 days after surgery

• Pain assessment (VAS score)

  Postoperative Day 0-28

Study Arms (2)

Experimental: VISOR

EXPERIMENTAL

Participants will undergo Vortex Intelligence Stone Optimized Removal.

Procedure: Vortex Intelligence Stone Optimized Removal

PCNL Group

ACTIVE COMPARATOR

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

Procedure: Percutaneous Nephrolithotomy (PCNL)

Interventions

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.

Experimental: VISOR

Percutaneous Nephrolithotomy (PCNL) PROCEDURE

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

PCNL Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 230000, China

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Bohan Wang, MD., Ph.D

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

CN (1)