Condition: Urolithiasis, Calcium Oxalate · Kidney Stone · Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
This description comes directly from the study's public registry record.
Bohan Wang, MD., Ph.D · +86-13575799866 · wangbohan@zju.edu.cn
Wenjun Gao, MD., Ph.D · +86-19817482099 · gaowenjun@zju.edu.cn
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| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou, Zhejiang, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07071948