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NCT Number: NCT07071948

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

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.

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Key information

Conditions

Urolithiasis, Calcium Oxalate Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stone Male Urogenital Diseases Nephrolithiasis Nephrolithiasis, Calcium Oxalate Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifunctional Integrated Flexible Ureteroscope

Device

Investigational ureteroscope with three integrated functions:

  • Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation/aspiration flow to maintain pressure <30 mmHg (safety threshold)
  • Simultaneous lithotripsy & fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel
  • Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures

Distinguishing features vs conventional ureteroscopes:

  • Eliminates need for separate suction devices
  • Prevents intraoperative "washout failure" causing obscured vision
  • Patent-pending pressure sensor

Other names: Xinwell Scope

Primary outcomes

  1. 24-hour stone-free rate after Xinwell Scope lithotripsy

    Time frame: 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.

Secondary outcomes

  1. 1-month stone-free rate

    Time frame: 28±7 days postoperatively

    Proportion of participants with residual stones <4 mm assessed by CT (if baseline residual ≥4 mm) or renal ultrasound (if no baseline residual) at 28±7 days post-surgery.

  2. Operative time

    Time frame: During surgery

    Duration (minutes) from initial ureteroscope insertion to final removal.

  3. Intraoperative renal pelvic pressure

    Time frame: Continuous monitoring during lithotripsy

    Mean/Max pressure (mmHg) recorded by built-in sensor. Safety target: <30 mmHg.

  4. Ureteral injury rate

    Time frame: During surgery

    Graded via intraoperative video review:

    Grade 0: Mucosal bleeding only

    Grade 1-4: Mucosal to full-thickness injury

  5. Postoperative complication rate

    Time frame: 24h, 28 ±7 days , 1 month

    Includes:

    Fever (>38.0°C within 24h)

    Clavien-Dindo grade ≥II complications

    Ureteral stenosis (imaging-confirmed at 1 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Bohan Wang, MD., Ph.D

CONTACT

[email protected]

+86-13575799866

Wenjun Gao, MD., Ph.D

CONTACT

[email protected]

+86-19817482099

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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