A Single-Center Clinical Study on the Efficacy and Safety of VISOR
A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)
Second Affiliated Hospital, School of Medicine, Zhejiang University
20 participants
Aug 6, 2025
INTERVENTIONAL
Conditions
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/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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
Investigational ureteroscope with three integrated functions: 1. Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation/aspiration flow to maintain pressure \<30 mmHg (safety threshold) 2. Simultaneous lithotripsy \& fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel 3. Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures Distinguishing features vs conventional ureteroscopes: 1. Eliminates need for separate suction devices 2. Prevents intraoperative "washout failure" causing obscured vision 3. Patent-pending pressure sensor
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07071948