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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medical device called the Xinwell Ureteroscope, designed to help adults with kidney or ureter stones that are 1 to 3 centimeters in size. The study aims to find out if this tool is safe and effective in breaking up and removing stones during surgery. The Xinwell Scope has special features like flushing, suction, and pressure control to help clear stones more easily while protecting the kidney during the procedure.

People who join the study will have surgery using the Xinwell Scope to remove their stones. A CT scan will be done within 24 hours after surgery to see how well the stones were cleared. Then, about four weeks later, participants will have another imaging test and a health check to make sure there are no problems from the surgery. To be eligible, participants must be adults between 18 and 80 years old with stones in the upper urinary tract that meet the size requirements, and they need to be able to understand the study and agree to take part. Certain conditions, like recent infections, pregnancy, past kidney surgery, or severe health problems, may exclude someone from joining. This study is currently recruiting patients who meet these criteria.

Gender

ALL

Eligibility criteria

• 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