A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 11
- 主要终点
- Stone Free Rate (SFR) - Zero Fragments
研究概览
简要总结
The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
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
- •Candidate for ureteroscopy with laser lithotripsy;
- •Presence of renal stone(s);
- •Be willing and able to return for all study-related follow up procedures; and,
- •Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.
排除标准
- •BMI > 45;
- •Significant comorbidities;
- •Bladder, ureteral or kidney abnormalities;
- •Pregnant individuals; or
- •Unable to meet the treatment and follow up protocol requirements.
研究组 & 干预措施
SURE
干预措施: SURE (Device)
Standard Ureteroscopy (Basketing)
干预措施: Standard Ureteroscopy (Basketing) (Device)
结局指标
主要结局
Stone Free Rate (SFR) - Zero Fragments
时间窗: 30 Days
The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm.
次要结局
- Residual Stone Volume (RSV)(30 Days)
- Stone Clearance (% Reduction in Stone Volume)(30 Days)