A Single-Center Clinical Study on the Efficacy and Safety of VISOR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multifunctional Integrated Flexible Ureteroscope.
- Who it may be relevant to
- Registry conditions: Urolithiasis, Calcium Oxalate, Kidney Stone. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)
Overview
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.
Interventions
- Device Multifunctional Integrated Flexible Ureteroscope
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 f
Primary outcome measures
- 24-hour stone-free rate after Xinwell Scope lithotripsy [Time frame: within 24 hours postoperatively]
Secondary outcome measures (5)
- 1-month stone-free rate [Time frame: 28±7 days postoperatively]
- Operative time [Time frame: During surgery]
- Intraoperative renal pelvic pressure [Time frame: Continuous monitoring during lithotripsy]
- Ureteral injury rate [Time frame: During surgery]
- Postoperative complication rate [Time frame: 24h, 28 ±7 days , 1 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT07071948 · 2025-0324