Kidney Calculi, Kidney Stones
Conditions
Brief summary
The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL). 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.
Interventions
PROCEDUREVortex 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.
PROCEDUREPercutaneous Nephrolithotomy (PCNL)
A standard PCNL technique will be performed according to institutional practice guidelines.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm * Age between 18 and 80 years, regardless of gender * Mentally sound and able to comprehend study details and provide informed consent
Exclusion criteria
* Presence of ureteral stricture or history thereof * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate within 24 hours | 24 hours after surgery | The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate at 1 month | 28 ± 7 days after surgery | The percentage of participants whose stones are completely cleared at 1 month after surgery, evaluated using CT or ultrasound. |
| Operative Time | During surgery (Day 0) | Total time from the beginning to the end of the surgery, measured in minutes. |
| Postoperative fever | 0-30 days after surgery | Incidence of participants experiencing a body temperature ≥38°C within 30 days after surgery. |
| Postoperative ureteral stricture | 28 ± 7 days after surgery | Occurrence of ureteral narrowing detected by imaging within 1 month after surgery. |
| Pain assessment (VAS score) | Postoperative Day 0-28 | Participants report their pain using the Visual Analog Scale (VAS) at different time points postoperatively. |
Countries
China
Outcome results
None listed