A Single-Center Clinical Study on the Efficacy and Safety of Xinwell Ureteroscope
- Conditions
- Urolithiasis, Calcium OxalateKidney Stone
- Registration Number
- NCT07071948
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
Goal of this trial:
To test a new tool called the Xinwell Scope 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 Xinwell Scope 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 the Xinwell Scope (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 injuryPostoperative 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)
Related Research Topics
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Trial Locations
- Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
2nd Affiliated Hospital, School of Medicine, Zhejiang University🇨🇳Hangzhou, Zhejiang, ChinaBohan Wang, MD., Ph.DContact+86-13575799866wangbohan@zju.edu.cnWenjun Gao, MD., Ph.DContact086-19817482099gaowenjun@zju.edu.cn