Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- To determine the efficiency of SP TFL in dusting stones
研究概览
简要总结
The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter)
- •Stones located in the kidney and proximal ureter
- •Stones measuring 10-30mm
- •Ability to give informed consent
- •Any racial or ethnic origin
- •Age 18 years and older
排除标准
- •Active kidney infection
- •Patients with prior stenting
- •Pregnant patients
- •Patients with solitary kidney
- •Patients with ureteral tumor or stricture
- •Inability to give informed consent
- •Not age 18 and older
结局指标
主要结局
To determine the efficiency of SP TFL in dusting stones
时间窗: 6 months
We plan to assess the direct impact of SP TFL to efficiently dust 10-30mm stones in the upper urinary tract . Metrics include time needed to ablate the stone i.e. ablation speed (stone volume mm3/sec)
Mean ablation energy needed to ablate stone volume
时间窗: 6 months
We plan to assess the direct impact of SP TFL to effectively dust 10-30mm stones in the upper urinary tract . Metrics include ablation energy needed to ablate the stone volume (Stone volume mm3/Joules)
次要结局
- Number of stones cleared.(9 months)
- Number of participants reporting complications.(9 months)