Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Scope performance
研究概览
简要总结
This study is designed to provide an evaluation of currently available disposable flexible ureteroscopes in real-world conditions. Due to high re-processing costs associated with re-usable flexible ureteroscopes, there has been a demand for Urologic device manufacturers to provide single-use flexible ureteroscopes.
详细描述
Patients randomized to the experimental group will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Data will be collected and stored electronically in REDCap. Quality assurance steps will include testing of the database, including any potential data calculated by command functions within REDCap
Scope performance survey will be administered with REDcap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females 18-89 undergoing ureteroscopy for laser treatment of renal calculi
- •Willing to sign the Informed Consent Form
- •Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
排除标准
- •Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)
- •Pregnancy
研究组 & 干预措施
Storz Flex-XC1 disposable flexible ureteroscope
A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
干预措施: Storz Flex-XC1 Disposable Flexible Ureteroscope (Device)
Digital ureteroscope
A patient is randomized to the experimental arm using a Digital ureteroscope.
干预措施: Storz Flexible Digital Ureteroscope (Device)
Analogue scope
A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
结局指标
主要结局
Scope performance
时间窗: 0-1 day
Difference in scope performance grading by multiple blinded reviewers
次要结局
- Operating room outcomes(0-1 day)
- Post-operative outcomes(4-6 weeks)
- Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference(4-6 weeks)
- Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)(4-6 weeks)
- Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)(4-6 weeks)
- Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference(4-6 weeks)
- Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view(4-6 weeks)
- Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression(4-6 weeks)
研究者
Amy Krambeck
Professor of Urology
Northwestern University