Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- If telemanipulator remained stable during procedure
研究概览
简要总结
In this pilot study, we wish to evaluate the performance of a robotic flexible ureteorscopy (ILY) in the treatment of nephrolithiasis in the superior excretory system
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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is at least 18 years old
- •The patient has a single kidney stone in the calyx or the pelvis between 5 and 15mm something to do with a JJ probe
- •Patient has an indication for in situ lithotripsy by supply ureteroscopy
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice or state guardianship
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is pregnant or breastfeeding
- •Patient treated with anticoagulants
- •Documented untreated urinary infection within the previous 48 hours
结局指标
主要结局
If telemanipulator remained stable during procedure
时间窗: end of procedure; less than 2 hours
Yes/no
Time taken to track kidney stones
时间窗: end of procedure; less than 2 hours
Number of procedures where the surgeon had to switch to manual mode or dedock the device
时间窗: end of study: 3 months
Time taken for complete exploration of renal cavities
时间窗: end of procedure; less than 2 hours
Docking time
时间窗: end of procedure; less than 2 hours
time between docking of device and use of gamepad
Laser fragmentation time
时间窗: end of procedure; less than 2 hours
Satisfaction of surgeon in using the device
时间窗: end of procedure; less than 2 hours
Custom-made questionnaire with 3 sections measuring: ease of use, ergonomics in exploration of renal cavities and stability during fragmentation of laser
Number of procedures performed entirely using the telemanipulator
时间窗: end of study: 3 months
Speed of fragmentation
时间窗: end of procedure; less than 2 hours
mm3/minute
Time of procedure
时间窗: end of procedure; less than 2 hours
Any joint pain strain experienced by the surgeon before and after intervention
时间窗: end of procedure; less than 2 hours
binary yes/no
次要结局
- Describe the rate of intra-operative complications during procedure(end of procedure; less than 2 hours)
- Integrity of the ureroscope at the end of the procedure(end of procedure; less than 2 hours)
- Describe the rate of intra-operative complications(1 month)