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

Not Applicable
Recruiting
Conditions
Urolithiasis, Calcium Oxalate
Kidney 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
24-hour stone-free rate after Xinwell Scope lithotripsywithin 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
NameTimeMethod
1-month stone-free rate28±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 timeDuring surgery

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

Intraoperative renal pelvic pressureContinuous monitoring during lithotripsy

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

Ureteral injury rateDuring surgery

Graded via intraoperative video review:

Grade 0: Mucosal bleeding only

Grade 1-4: Mucosal to full-thickness injury

Postoperative complication rate24h, 28 ±7 days , 1 month

Includes:

Fever (\>38.0°C within 24h)

Clavien-Dindo grade ≥II complications

Ureteral stenosis (imaging-confirmed at 1 months)

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, China
Bohan Wang, MD., Ph.D
Contact
+86-13575799866
wangbohan@zju.edu.cn
Wenjun Gao, MD., Ph.D
Contact
086-19817482099
gaowenjun@zju.edu.cn

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