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

Zhejiang University

Status: Enrolling

Conditions: Kidney Stone; Urolithiasis, Calcium Oxalate

Treatments: Device: Multifunctional Integrated Flexible Ureteroscope

Study type: Interventional

Funder types: Other

Identifiers

NCT07071948

2025-0324

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Patients who choose to undergo "flexible ureteroscopic holmium laser lithotripsy"
3. Aged 18-80 years, regardless of gender
4. Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form

Exclusion criteria

1. Patients with ureteral stricture or a history of ureteral stricture
2. Patients with a history of open renal and/or ureteral surgery or laparoscopic surgery
3. Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery
4. Pregnant women, lactating women, or women who are in the menstrual period
5. 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
6. Patients with anatomical malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney
7. Patients with abnormal coagulation function (e.g., international normalized ratio (INR) > 1.5 or platelet count < 80 × 10⁹/L)
8. Patients with failed sheath placement during surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

VISOR Treatment

Experimental group

Description:

All enrolled participants (n=20) will undergo upper urinary tract stone removal using the investigational device VISOR (Vortex Intelligence Stone Optimized Removal). The procedure includes: 1. Integrated irrigation-aspiration and real-time pressure monitoring/control (safety threshold: \<30 mmHg). 2. Holmium laser lithotripsy with simultaneous stone fragment removal. 3. Postoperative assessment: Urinary CT scan at 24h to determine immediate stone-free rate (residual stones \<4 mm). Follow-up imaging (CT/ultrasound) and complication monitoring at 28±7 days.

Treatment:

Device: Multifunctional Integrated Flexible Ureteroscope