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

NCT07071948 | Recruiting

• 1 other identifier: 2025-0324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.If it's safe and works well
2. 2.If its built-in features (flushing/suction, pressure control, and stone-breaking/removal) help clear stones better while keeping surgery safe.
3. 3.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?
4. 4.Will serious problems (like severe infections or ureteral injuries) happen to no more than 1 in 20 people (5%)?
5. 5.Can the device keep pressure inside the kidney below 30 mmHg (a safe level) during the entire surgery?

Conditions

Urolithiasis, Calcium Oxalate; Kidney Stone

Keywords

urolithiasis; kidney stone; stone free rate; VISOR

Outcome Measures

Primary Outcomes (1)

• 24-hour stone-free rate after Xinwell Scope lithotripsy

  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.

  within 24 hours postoperatively

Secondary Outcomes (5)

• 1-month stone-free rate

  28±7 days postoperatively

• Operative time

  During surgery

• Intraoperative renal pelvic pressure

  Continuous monitoring during lithotripsy

• Ureteral injury rate

  During surgery

• Postoperative complication rate

  24h, 28 ±7 days , 1 month

Study Arms (1)

VISOR Treatment

EXPERIMENTAL

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.

Device: Multifunctional Integrated Flexible Ureteroscope

Interventions

Multifunctional Integrated Flexible Ureteroscope 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

Also known as: Xinwell Scope

VISOR Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 230000, China

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis, Calcium Oxalate; Kidney Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bohan Wang, MD., Ph.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bohan Wang, MD., Ph.D

CONTACT

+86-13575799866; wangbohan@zju.edu.cn

Wenjun Gao, MD., Ph.D

CONTACT

+86-19817482099; gaowenjun@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 18, 2025
• Study Start: August 6, 2025
• Primary Completion: October 31, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)