NCT07071948 A Single-Center Clinical Study on the Efficacy and Safety of VISOR
| NCT ID | NCT07071948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Urolithiasis, Calcium Oxalate |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08-06 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Goal of this trial: To test a new tool called VISOR 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 VISOR 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 VISOR (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.
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
Contact & Investigator
Bohan Wang, MD., Ph.D
PRINCIPAL INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT07071948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Urolithiasis, Calcium Oxalate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07071948 currently recruiting?
Yes, NCT07071948 is actively recruiting participants. Contact the research team at wangbohan@zju.edu.cn for enrollment information.
Where is the NCT07071948 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07071948 clinical trial?
NCT07071948 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Bohan Wang, MD., Ph.D at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 20 participants.