A Single-Center Clinical Study on the Efficacy and Safety of VISOR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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
Qualifiers
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
Patients who choose to undergo "flexible ureteroscopic holmium laser lithotripsy"
Aged 18-80 years, regardless of gender
Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form
Disqualifiers
Patients with ureteral stricture or a history of ureteral stricture
Patients with a history of open renal and/or ureteral surgery or laparoscopic surgery
Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery
Pregnant women, lactating women, or women who are in the menstrual period
Trial design
Treatments tested in this trial
- Multifunctional Integrated Flexible Ureteroscope
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov