First Clinical Evaluation of the New Flexible Disposable Ureteroscope (LithoVue Elite): A Multicenter Single-arm Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- WISQOL
研究概览
简要总结
Flexible ureteroscopy has become the main surgical treatment for kidney stone disease. The procedure uses many types of ureteroscopes (disposable and non-disposable). Currently we are using the LithoVue Single-Use Digital Flexible Ureteroscope. The Health Canada approved LithoVue Elite disposable flexible ureteroscope will now offer novel pressure sensory capacity. In order to evaluate the new ureteroscopy we will be conducting a prospective multi-institution study in order to determine the main features, capacity and abilities of the new scope. We will evaluate the impact of intra renal pressure on pain, quality of life and possible infectious complications.
详细描述
This is a single arm multicenter study looking at real world results of ureteroscopy with the new digital flexible ureteroscope LVE. The study will involve 6 participating institutions. Each site will be in charge of recruiting 25 participants for a total of 150 participants.
Hypothesis:
- The single-use flexible ureteroscope (Lithovue Elite) will provide equivalent overall performance to a standard-of-care reusable or disposable ureteroscope as determined by:
- Stone-free rate following ureteroscopy at 4-8 weeks post-procedure
- Equivalent adjunctive procedures in the postoperative period
- Intraoperative assessment parameters will show no difference between the Lithovue Elite scope and other standard-of-care ureteroscopes
- Elevated intrarenal pressures during ureteroscopes will result in:
- Higher post-operative pain intensity as documented in the Brief Pain Inventory-BPI
- Lower quality of life as reflected via Wisconsin Stone Quality of Life Questionnaire scores
- Higher rates of infections complications
- Changes in neutrophil gelatinase-associated lipocalin (NGAL) from baseline
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
- •Patient scheduled for ureteroscopy and laser lithotripsy
- •Non-obstructing renal stone 2 cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing flexible ureteroscopy
- •age > 18 years
排除标准
- •age < 18 years
- •pregnancy status =positive
- •indwelling nephrostomy tube
- •severe hydronephrosis that in the opinion of the investigator, will make it challenging to make the patient stone free
- •renal anomalies
结局指标
主要结局
WISQOL
时间窗: At baseline, 1-2 weeks after surgery and 4-8 weeks after surgery
Change in quality of Life of patients living with kidney stones as assessed by the Winsconsin Stone Quality Of Life questionnaire
次要结局
- Stone free rate(4-8 weeks after surgery)
- Infectious Complications(at 30 days after surgery)
- BPI(at baseline, in the recovery room after surgery, 1-2 weeks after surgery and 4-8 weeks after surgery)
- Complications(at 30 days after surgery)
- Change in neutrophil gelatinase-associated lipocalin (NGAL) from baseline(at baseline and in the recovery room after surgery)