Prospective Randomized Controlled Clinical Trial on the Treatment of Upper Urinary Tract Stones With VISOR and fURS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Immediate Postoperative Stone-Free Rate (SFR):
研究概览
简要总结
This prospective randomized controlled clinical study aims to evaluate the safety and efficacy of a novel Vortex Intelligence Stone Optimized Removal (VISOR,The experimental group) system compared to a single-use ureterorenoscope (the control) for treating upper urinary tract stones.
A total of 100 patients with upper urinary tract stones (cumulative stone diameter ≤3 cm) will be enrolled and randomly assigned in a 1:1 ratio to either the experimental group (n=50) or the control group (n=50). The experimental group will undergo surgery using the innovative system, which integrates irrigation-suction, pressure monitoring-regulation, and lithotripsy-evacuation functions. The control group will be treated with a conventional single-use ureterorenoscope.
The primary outcome measure is the immediate stone-free rate (SFR), defined as the proportion of patients with residual fragments <4 mm on renal non-contrast computed tomography (NCCT) performed within 24 hours postoperatively. Key secondary endpoints include the SFR at 3 months, operative and lithotripsy times, total laser energy used, intraoperative ureteral injury (Traxer grading), postoperative pain scores, incidence of fever (>38.0°C), and overall complication rates (Clavien-Dindo classification).
Patient follow-up assessments will be conducted at 24 hours, 21±7 days, and 90±14 days post-surgery to monitor stone clearance, complications, and recovery. This study seeks to determine if the novel system offers superior stone clearance while maintaining a safe renal pelvic pressure profile, potentially improving outcomes for patients with larger renal stones treated ureteroscopically.
详细描述
- Study Background and Rationale
Urolithiasis is a highly prevalent urological disease, ranking first among inpatient admissions in urology departments. It is characterized by high incidence and recurrence rates. In China, the incidence ranges from 1% to 5%, with higher rates in the eastern and southern regions, reaching 5-10% in the south. Approximately 150-200 new cases per 100,000 people require hospitalization each year, with a rising trend establishing China as one of the world's three high-risk regions for stones.
The primary surgical treatments for renal stones are flexible ureteroscopy (fURS) and percutaneous nephrolithotomy (PCNL). fURS, utilizing the natural urinary tract, is minimally invasive with fewer complications but is limited by lower lithotripsy efficiency, making it guideline-recommended for stones <2cm. PCNL, while highly efficient for stones >2cm, carries higher risks, including significant bleeding and potential injury to adjacent organs.
There is a growing trend to use fURS for larger stones (>2cm), yet several challenges remain:
Low Lithotripsy Efficiency: Small working channels limit laser fiber size, requiring dusting, which clouds the visual field.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with upper urinary tract stones and a cumulative stone diameter ≤3 cm;
- •Patients scheduled to undergo "flexible ureteroscopic holmium laser lithotripsy";
- •Age ≥18 years;
- •Patients without psychiatric disorders or language dysfunction, capable of understanding the study and providing informed consent.
排除标准
- •Patients requiring bilateral lithotripsy in a single-stage ureteroscopic procedure;
- •Ipsilateral hydronephrosis with >4 cm renal pelvic separation;
- •Patients with a history of open or laparoscopic renal and/or ureteral surgery;
- •Fever (body temperature ≥38°C) due to urinary tract infection or other causes within one week prior to surgery;
- •Pregnant women;
- •Patients with severe systemic diseases, cardiac diseases, pulmonary insufficiency, or vital organ failure unable to tolerate anesthesia or surgery (ASA score ≥3);
- •Patients with anatomical abnormalities such as polycystic kidney, horseshoe kidney, or ectopic kidney;
- •Patients with coagulation disorders (e.g., INR >2.0 or platelet count <80×10⁹/L);
- •Patients currently participating in other device or drug clinical trials;
- •Patients deemed ineligible for the trial by the investigator.
结局指标
主要结局
Immediate Postoperative Stone-Free Rate (SFR):
时间窗: 24 hours after surgery
Stone clearance rate within 24 hours after surgery.
次要结局
- Stone-Free Rate at 3 Months Postoperatively(3 Months Postoperatively)