A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (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.
• 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