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

NCT07071948 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-26

No results posted yet for this 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.

Conditions

  • Urolithiasis, Calcium Oxalate
  • Kidney Stone

Interventions

DEVICE

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Bohan Wang, MD., Ph.D · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2025-10-31
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071948 on ClinicalTrials.gov