A Prospective Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® Set
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Stone Clearance
研究概览
简要总结
The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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;
- •Be willing and able to return for and respond to all study-related follow up procedures; and,
- •Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).
排除标准
- •Significant morbidities;
- •Unable to meet the treatment and follow up protocol requirements; and,
- •Ureteral or kidney abnormalities.
研究组 & 干预措施
Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
干预措施: Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System (Device)
结局指标
主要结局
Stone Clearance
时间窗: Day 1 and Day 30
The stone clearance at Post-Op Day 1 (POD1) and Post-Op Day 30 (POD30) on non-contrast CT (NCCT)
Stone Clearance (% Reduction in Stone Volume)
时间窗: 30 Days
The percent reduction (\[Baseline stone volume- 30-Day stone volume\] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure.
Residual Stone Volume (RSV)
时间窗: 30 Days
A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
Stone Free Rate (SFR) - Zero Fragments
时间窗: 30 Days
Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm.
次要结局
未报告次要终点