VISOR for removing 1–3 cm kidney and ureter stones
A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)
This will test a new device called VISOR to break up and remove 1–3 cm kidney or ureter stones in adults aged 18–80.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07071948 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with upper urinary tract stones totaling 1–3 cm who opt for flexible ureteroscopic holmium laser lithotripsy and can give informed consent are ideal candidates.
Not a fit: Patients with ureteral strictures, prior open or laparoscopic renal/ureter surgery, recent fever from infection, pregnant or lactating women, or those with ASA class >3 are excluded and unlikely to benefit in this study.
Why it matters
Potential benefit: If successful, VISOR could increase the share of patients who are quickly stone-free after ureteroscopic surgery while reducing pressure-related complications.
How similar studies have performed: Some ureteroscopes with suction and pressure-control features have shown promising results in small studies, but VISOR's particular combination of functions is relatively new and less well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.