Health TrialsbyHealthPanel

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

ConditionsUrolithiasis, Calcium OxalateKidney Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: VISOR TreatmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
within 24 hours postoperatively

Secondary outcomes

1

1-month stone-free rate

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.

Time frame
28±7 days postoperatively
2

Operative time

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

Time frame
During surgery
3

Intraoperative renal pelvic pressure

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

Time frame
Continuous monitoring during lithotripsy
4

Ureteral injury rate

Graded via intraoperative video review: Grade 0: Mucosal bleeding only Grade 1-4: Mucosal to full-thickness injury

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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