Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Stone-free rate within 24 hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Stone-free rate within 24 hours
时间窗: 24 hours after surgery
The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.
次要结局
- Stone-free rate at 1 month(28 ± 7 days after surgery)
- Operative Time(During surgery (Day 0))
- Postoperative fever(0-30 days after surgery)
- Postoperative ureteral stricture(28 ± 7 days after surgery)
- Pain assessment (VAS score)(Postoperative Day 0-28)