Status:
ENROLLING_BY_INVITATION
VISOR Versus PCNL for Treatment of 2-4cm Renal Stones
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Kidney Calculi
Kidney Stones
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT07159503
Start Date
April 20 2025
End Date
August 20 2027
Last Update
September 12 2025
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 230000