An interventional study of Multifunctional Integrated Flexible Ureteroscope in Urolithiasis, Calcium Oxalate and Kidney Stone, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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:
Main questions:
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 20 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled participants (n=20) will undergo upper urinary tract stone removal using the investigational device VISOR (Vortex Intelligence Stone Optimized Removal). The procedure includes: 1. Integrated irrigation-aspiration and real-time pressure monitoring/control (safety threshold: \<30 mmHg). 2. Holmium laser lithotripsy with simultaneous stone fragment removal. 3. Postoperative assessment: Urinary CT scan at 24h to determine immediate stone-free rate (residual stones \<4 mm). Follow-up imaging (CT/ultrasound) and complication monitoring at 28±7 days.
Device: Multifunctional Integrated Flexible Ureteroscope
Investigational ureteroscope with three integrated functions: 1. Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation/aspiration flow to maintain pressure \<30 mmHg (safety threshold) 2. Simultaneous lithotripsy \& fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel 3. Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures Distinguishing features vs conventional ureteroscopes: 1. Eliminates need for separate suction devices 2. Prevents intraoperative "washout failure" causing obscured vision 3. Patent-pending pressure sensor
Also known as: Xinwell Scope
24-hour stone-free rate after Xinwell Scope lithotripsy
Proportion of participants with complete stone clearance (defined as no residual fragment ≥4 mm in maximum diameter) assessed by non-contrast urinary CT scan within 24 hours post-surgery. Calculated as: (Number of patients with residual stones \<4 mm / Total analyzed participants) × 100% Significance: Directly evaluates the device's integrated suction function for real-time fragment removal during the procedure.
Time frame: within 24 hours postoperatively
1-month stone-free rate
Proportion of participants with residual stones \<4 mm assessed by CT (if baseline residual ≥4 mm) or renal ultrasound (if no baseline residual) at 28±7 days post-surgery.
Time frame: 28±7 days postoperatively
Operative time
Duration (minutes) from initial ureteroscope insertion to final removal.
Time frame: During surgery
Intraoperative renal pelvic pressure
Mean/Max pressure (mmHg) recorded by built-in sensor. Safety target: \<30 mmHg.
Time frame: Continuous monitoring during lithotripsy
Ureteral injury rate
Graded via intraoperative video review: Grade 0: Mucosal bleeding only Grade 1-4: Mucosal to full-thickness injury
Time frame: During surgery
Postoperative complication rate
Includes: Fever (\>38.0°C within 24h) Clavien-Dindo grade ≥II complications Ureteral stenosis (imaging-confirmed at 1 months)
Time frame: 24h, 28 ±7 days , 1 month
Plan to share: No — Intellectual Property Protection The investigational device (Xinwell Scope) contains patent-pending technologies owned by Ningbo Xinwell Medical Technology Co., Ltd. Public disclosure of raw performance data (e.g., real-time pelvic pressure metrics) may compromise proprietary algorithms. Privacy Risks of De-identified Data Key datasets (intraoperative videos, dynamic pressure recordings) carry re-identification risks despite de-identification.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Oct 2025, 2 months after the start.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 2 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →