Kidney Stone, Urolithiasis, Calcium Oxalate
Conditions
Keywords
urolithiasis, kidney stone, stone free rate, VISOR
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.
Interventions
DEVICEMultifunctional 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
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour stone-free rate after Xinwell Scope lithotripsy | 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
| Measure | Time frame | Description |
|---|---|---|
| 1-month stone-free rate | 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. |
| Operative time | During surgery | Duration (minutes) from initial ureteroscope insertion to final removal. |
| Intraoperative renal pelvic pressure | Continuous monitoring during lithotripsy | Mean/Max pressure (mmHg) recorded by built-in sensor. Safety target: \<30 mmHg. |
| Ureteral injury rate | During surgery | Graded via intraoperative video review: Grade 0: Mucosal bleeding only Grade 1-4: Mucosal to full-thickness injury |
| Postoperative complication rate | 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) |
Countries
China
Contacts
Primary ContactBohan Wang, MD., Ph.D
Backup ContactWenjun Gao, MD., Ph.D
Outcome results
None listed