Clinical Trial of VISOR vs fURS for Upper Urinary Tract Stone (NCT07181759) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Trial of VISOR vs fURS for Upper Urinary Tract Stone
100 participantsStarted 2025-09-20
Plain-language summary
This prospective randomized controlled clinical study aims to evaluate the safety and efficacy of a novel Vortex Intelligence Stone Optimized Removal (VISOR,The experimental group) system compared to a single-use ureterorenoscope (the control) for treating upper urinary tract stones.
A total of 100 patients with upper urinary tract stones (cumulative stone diameter ≤3 cm) will be enrolled and randomly assigned in a 1:1 ratio to either the experimental group (n=50) or the control group (n=50). The experimental group will undergo surgery using the innovative system, which integrates irrigation-suction, pressure monitoring-regulation, and lithotripsy-evacuation functions. The control group will be treated with a conventional single-use ureterorenoscope.
The primary outcome measure is the immediate stone-free rate (SFR), defined as the proportion of patients with residual fragments \<4 mm on renal non-contrast computed tomography (NCCT) performed within 24 hours postoperatively. Key secondary endpoints include the SFR at 3 months, operative and lithotripsy times, total laser energy used, intraoperative ureteral injury (Traxer grading), postoperative pain scores, incidence of fever (\>38.0°C), and overall complication rates (Clavien-Dindo classification).
Patient follow-up assessments will be conducted at 24 hours, 21±7 days, and 90±14 days post-surgery to monitor stone clearance, complications, and recovery. This study seeks to determine if the novel system offers superior stone clearance while maintaining a safe renal pelvic pressure profile, potentially improving outcomes for patients with larger renal stones treated ureteroscopically.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with upper urinary tract stones and a cumulative stone diameter ≤3 cm;
* Patients scheduled to undergo "flexible ureteroscopic holmium laser lithotripsy";
* Age ≥18 years;
* Patients without psychiatric disorders or language dysfunction, capable of understanding the study and providing informed consent.
Exclusion Criteria:
* Patients requiring bilateral lithotripsy in a single-stage ureteroscopic procedure;
* Ipsilateral hydronephrosis with \>4 cm renal pelvic separation;
* Patients with a history of open or laparoscopic renal and/or ureteral surgery;
* Fever (body temperature ≥38°C) due to urinary tract infection or other causes within one week prior to surgery;
* Pregnant women;
* Patients with severe systemic diseases, cardiac diseases, pulmonary insufficiency, or vital organ failure unable to tolerate anesthesia or surgery (ASA score ≥3);
* Patients with anatomical abnormalities such as polycystic kidney, horseshoe kidney, or ectopic kidney;
* Patients with coagulation disorders (e.g., INR \>2.0 or platelet count \<80×10⁹/L);
* Patients currently participating in other device or drug clinical trials;
* Patients deemed ineligible for the trial by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.