A Single-Center Clinical Study on the Efficacy and Safety of VISOR

Condition(s) studied

Investigational drug(s) / intervention(s)

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 features vs conventional ureteroscopes: 1. Eliminates need for separate suction devices 2. Prevents intraoperative "washout failure" causing obscured vision 3. Patent-pending pressure sensor

Study 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

Primary outcome measure(s)

• 24-hour stone-free rate after Xinwell Scope lithotripsy — within 24 hours postoperatively
  Proportion of participants with complete stone clearance (defined as no residual fragment ≥4 mm in maximum diameter) assessed by non-contrast urinary CT scan within 24 hours post-surgery. Calculated as: (Number of patients with residual stones \<4 mm / Total analyzed participants) × 100% Significance: Directly evaluates the device's integrated suction function for real-time fragment removal during the procedure.

Trial sites (1)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China