A Single-Center Clinical Study on the Efficacy and Safety of VISOR

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/suction, pressure control, and stone-breaking/removal) help clear stones better while keeping surgery safe. Main questions: 1. Can the VISOR clear stones successfully (with fragments \<4 mm left) for at least 9 out of every 10 people within 24 hours after surgery? 2. Will serious problems (like severe infections or ureteral injuries) happen to no more than 1 in 20 people (5%)? 3. Can the device keep pressure inside the kidney below 30 mmHg (a safe level) during the entire surgery? What participants will do: Have stone removal surgery using VISOR (breaks and removes stones at the same time). Get a CT scan within 24 hours after surgery to check if stones are cleared. Return 4 weeks (±1 week) after surgery for: An imaging test (CT or ultrasound) A check for any health problems related to the surgery.

NCT Number	NCT07071948
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Urolithiasis, Calcium Oxalate, Kidney Stone
Enrollment	20 participants
Start Date	2025-08-06
Primary Completion	2025-10-31 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-09-26