VISOR for removing 1–3 cm kidney and ureter stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional study uses the VISOR multifunctional integrated flexible ureteroscope during flexible ureteroscopic holmium laser lithotripsy to break and remove upper urinary tract stones 1–3 cm in size. During surgery VISOR's features—flushing/suction, pressure control, and simultaneous stone fragmentation/removal—are used and intrarenal pressure is monitored to keep it below 30 mmHg. Success is defined as stone fragments <4 mm on a CT scan obtained within 24 hours after surgery, and safety is tracked by recording serious complications through a 4-week follow-up visit. The trial aims to see if at least 90% of participants are stone-free within 24 hours and if serious adverse events occur in no more than 5% of cases.

Why it matters

Who can join: the full rules

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

Where it's running

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Bohan Wang, MD., Ph.D — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Bohan Wang, MD., Ph.D
• Email: wangbohan@zju.edu.cn
• Phone: +86-13575799866

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.