Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Stone-free status
研究概览
简要总结
Most flexible ureteroscopes that are used to treat kidney stones have been reusable. Recently, advances in technology have resulted in single-use (disposable) ureteroscopes to become available. The investigators are interested in determining if the performance of the two types of scopes are equivalent. This will help guide institutions in the future to purchase the best scopes for their patients.
详细描述
Ureteroscopy is commonly used in the treatment of kidney stones. Flexible ureteroscopes are costly to purchase and repair. Issues with flexible ureteroscopes include loss of deflection and visual performance (fiberoptic pixels) with use and the high repair costs. Reprocessing and sterilization of reusable ureteroscopes also requires staff who are specially trained and dedicated in this area. Inadequate sterilization could also lead to transmissible infections between patients. A single-use flexible digital ureteroscope has recently become commercially available (LithoVue, Boston Scientific, Marlborough, MA). Pre-clinical testing show the accessibility to the ureter and all areas of the kidney to be equivalent to current flexible ureteroscopes. However, clinical data comparing this single-use ureteroscope to a current state of the art reusable ureteroscope is lacking. Establishing at least equivalence in performance between the new single use ureteroscope and a reusable digital ureteroscope will help surgeons and operating room managers/administrators help determine how to most efficiently equip their operating rooms with endoscopic equipment.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm)
- •19 years or older and able to provide informed consent
排除标准
- •patients < 18 years
- •patients with known nephrocalcinosis .
- •any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.
结局指标
主要结局
Stone-free status
时间窗: 6-10 weeks
Overall kidney stone burden that remains post ureteroscopy (if any)
次要结局
- Secondary procedures and/or unanticipated clinical events(4-6 weeks post operatively)
- Case completion with one scope(Day of procedure)
- Maintenance and Repair(Through study completion, an average of 8 months)
- Scope optics (visual quality of the image provided by the scope)(Day of procedure)
研究者
Ben Chew, MD
Associate Professor of Urology
University of British Columbia