Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
170 participants
INTERVENTIONAL
2025-04-20
2027-08-20
Brief Summary
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The main questions it aims to answer are:
How many participants are stone-free within 24 hours after surgery?
How many participants are stone-free 1 month after surgery?
What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL?
Does VISOR help keep kidney pressure stable during surgery?
Researchers will compare VISOR to PCNL to see which treatment works better and is safer.
Participants will:
Be randomly assigned to have surgery with either VISOR or PCNL.
Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared.
Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging.
About 170 people will take part in this study at cooperative hospitals.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: VISOR
Participants will undergo Vortex Intelligence Stone Optimized Removal.
Vortex Intelligence Stone Optimized Removal
Vortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications.
PCNL Group
Participants undergo standard percutaneous nephrolithotomy (PCNL) for renal stone removal.
Percutaneous Nephrolithotomy (PCNL)
A standard PCNL technique will be performed according to institutional practice guidelines.
Interventions
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Vortex Intelligence Stone Optimized Removal
Vortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications.
Percutaneous Nephrolithotomy (PCNL)
A standard PCNL technique will be performed according to institutional practice guidelines.
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 80 years, regardless of gender
* Mentally sound and able to comprehend study details and provide informed consent
Exclusion Criteria
* Previous open or laparoscopic renal and/or ureteral surgery
* Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery
* Pregnancy, lactation, or menstruation at the time of surgery
* ASA classification \> Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery
* Renal anatomical anomalies such as polycystic kidney, horseshoe kidney, or ectopic kidney
* Coagulation dysfunction (e.g., INR \> 1.5 or platelet count \< 80 × 10⁹/L)
* Intraoperative failure to successfully place the ureteral access sheath
18 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Bohan Wang, MD., Ph.D
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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2025-134
Identifier Type: -
Identifier Source: org_study_id
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