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

NCT ID: NCT07071948

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-06
• Study Completion Date: 2027-02-28

Brief 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.

Conditions

Urolithiasis, Calcium Oxalate; Kidney Stone

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VISOR Treatment

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.

Group Type: EXPERIMENTAL

Multifunctional Integrated Flexible Ureteroscope

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Xinwell Scope

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bohan Wang, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bohan Wang, MD., Ph.D

Role: CONTACT

wangbohan@zju.edu.cn

+86-13575799866

Wenjun Gao, MD., Ph.D

Role: CONTACT

gaowenjun@zju.edu.cn

+86-19817482099

Facility Contacts

Bohan Wang, MD., Ph.D

Role: primary

wangbohan@zju.edu.cn

+86-13575799866

Wenjun Gao, MD., Ph.D

Role: backup

gaowenjun@zju.edu.cn

086-19817482099

Other Identifiers

2025-0324

Identifier Type: -

Identifier Source: org_study_id