Status:
RECRUITING
A Single-Center Clinical Study on the Efficacy and Safety of VISOR
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Urolithiasis, Calcium Oxalate
Kidney Stone
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Goal of this trial: To test a new tool called VISOR in adults (aged 18-80) with 1-3 cm kidney or ureter stones. We want to see: 1. If it's safe and works well 2. If its built-in features (flushing/s...
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 1-3 cm
- Patients who choose to undergo "flexible ureteroscopic holmium laser lithotripsy"
- Aged 18-80 years, regardless of gender
- Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form
Exclusion Criteria:
- Patients with ureteral stricture or a history of ureteral stricture
- Patients with a history of open renal and/or ureteral surgery or laparoscopic surgery
- Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery
- Pregnant women, lactating women, or women who are in the menstrual period
- ASA classification > Grade 3: patients with severe systemic diseases, heart diseases, pulmonary insufficiency, and failure of important organ functions, etc., who cannot tolerate anesthesia or surgery
- Patients with anatomical malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney
- Patients with abnormal coagulation function (e.g., international normalized ratio (INR) > 1.5 or platelet count < 80 × 10⁹/L)
- Patients with failed sheath placement during surgery
Key Trial Info
Start Date :
August 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07071948
Start Date
August 6 2025
End Date
February 28 2027
Last Update
September 26 2025
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 230000