Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Stone Clearance
研究概览
简要总结
Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
详细描述
This is a randomized, two-arm, prospective, single center study. Subjects will undergo a single flexible ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study device, and will be treated as randomized to either stone breaking treatment or stone dusting treatment. Follow up visits are scheduled for the day of release from the hospital and at 1 month post procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part of the site standard of practice. Additional treatment sessions will not be included in this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject will be older than 18 years of age
- •Subject was diagnosed with renal calculi meeting the following criteria:
- •Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
- •Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
- •Subject is a candidate for FURS procedure
- •Subject is willing and has signed the Informed Consent Form
排除标准
- •Subject has undergone a previous treatment for stones in the same kidney
- •Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
- •Female subject is pregnant
- •Concomitant anticoagulant medication that cannot be suspended during surgery
研究组 & 干预措施
Stone breaking
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
干预措施: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber (Device)
Stone dusting
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
干预措施: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber (Device)
结局指标
主要结局
Stone Clearance
时间窗: Stone clearance based on 1 month follow-up imaging data
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Post-procedure Catheterization
时间窗: Post-procedure through hospital discharge; typically discharge occurs on the same day or 1 day post procedure
Post-procedure catheterization by group
Procedure Time
时间窗: during the procedure
Duration (in minutes) of the procedure as an indicator for treatment efficiency.
Usage of Alternative Stone Extracting Devices
时间窗: as measured during the procedure
The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.
Hospital Stay
时间窗: Procedure through hospital discharge
Hospital duration was measured to evaluate treatment efficiency
次要结局
- Number of Participants With Intraoperative Complications(Intraoperative)
- Visibility During Procedure(Intraprocedural)
- Number of Participants With Occurrence of Retropulsion(Intraoperative)
- Ability to Reach Stone Fragments(Intraoperative)
- Damage to Scope or Fiber(Intraoperative)
- Fiber Transmission(Intraoperative)