Actively Recruiting
A Single-Center Clinical Study on the Efficacy and Safety of VISOR
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-26
20
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Single-Center Clinical Study on the Efficacy and Safety of VISOR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with upper urinary tract stones sized 1-3 cm in total diameter
- Patients who choose to have flexible ureteroscopic holmium laser lithotripsy
- Aged 18 to 80 years, any gender
- Able to understand the study and provide informed consent without mental illness or language problems
You will not qualify if you...
- History of ureteral stricture or current ureteral stricture
- History of open or laparoscopic kidney or ureter surgery
- Fever (temperature 386C or higher) due to urinary infection or other causes within one week before surgery
- Pregnant, breastfeeding, or menstruating women
- Severe systemic disease or organ failure making anesthesia or surgery unsafe (ASA classification above Grade 3)
- Anatomical kidney malformations like polycystic kidney, horseshoe kidney, or ectopic kidney
- Abnormal blood clotting (INR > 1.5 or low platelet count below 80 �d7 10�b9/L)
- Failed sheath placement during surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 230000
Actively Recruiting
Research Team
B
Bohan Wang, MD., Ph.D
CONTACT
W
Wenjun Gao, MD., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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