Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser in Ureteroscopic Management of Kidney Stones 10-20mm: A Randomized Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Procedural Time
研究概览
简要总结
This study aims to compare the efficacy and safety of both types of lasers, Holmium MOSES and TFL, in management of kidney stones requiring treatment.
详细描述
The prevalence of kidney stones has been increasing over the last two decades with lifetime recurrence risk reported to be as high as 50%. Holmium lasers are nowadays considered the "gold standard" for treatment of urinary tract stones.
Recently, the holmium laser urology platform from Lumenis has been updated to include a new technology called MOSES, which provides improved energy delivery of the laser to treat the stones, reduces migration of the stone during the procedure, and limits potential collateral tissue damage.
A new generation of lasers has evolved due to the advances in laser fiber technology, leading to the development of the Thulium Fiber Laser (TFL). TFL can operate within a large range of energy, frequency and pulse duration settings. The small fiber size is one of the main advantages of TFL, as it allows better endoscope performance through easier deflection and bigger working channel space. Furthermore, it produces small stone fragments and better dusting capabilities compared to the standard Holmium laser when adjusted on the same power settings.
This study will compare the efficacy and safety of Holmium MOSES and TFL in management of kidney stones requiring treatment.
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
- •18 years of age and over at the time of enrollment.
- •Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
- •Written informed consent to participate in the study
- •Ability to comply with the requirements of the study procedures
排除标准
- •Patients with ipsilateral distal ureteral stones or stricture.
- •Stone size > 20 mm or multiple kidney stones in different calyces.
- •Previous shock wave lithotripsy (SWL) treatment for the same stone.
- •Participants with active urinary tract infection until appropriately treated
- •Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
- •Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- •Participants who are uncooperative or cannot follow instructions.
- •Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.
- •Patients with solitary kidney.
结局指标
主要结局
Procedural Time
时间窗: Intraoperative
Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.
次要结局
- Total operative time(Intraoperative)
- Lasing time(Intraoperative)
- Percentage of Patients with Post-op Complications(4 weeks)
- Total energy used(Intraoperative)
- Laser efficiency(Intraoperative)
- Number of times the laser pedals are pressed(Intraoperative)
- Stone Free Rate (SFR)(4 and 12 weeks post-op)