A Randomized Controlled Trial Comparing Efficacy of HM3 vs F2 Lithotripters for Stone Fragmentation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Stone free rate, complications and need for ancillary procedures
研究概览
简要总结
The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less transportable than the new model, F2. There are no prospective trials performed to make a valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation and clinical outcomes.
详细描述
Shock wave kidney stone treatment was introduced in the 1980's. It is the least invasive method to treat kidney stone disease. The unmodified Dornier HM3 has over 90% stone free rate in most studies. The MH3 requires immersion in a full bath, necessitating dedicated operative space. The new generation model F2 uses water cushion as a coupling medium and is easily transported. The generators used in both machines are also different. The newer model has the advantage of being more convenient due to portability and ease of use of the coupling medium, but there have been no prospective studies to compare these 2 machines in terms of efficacy of stone fragmentation and clinical outcomes. We seek to compare the HM3 with the F2 models in terms of stone free rates, complications and clinical outcomes to determine which machine is the most effective and will limit the need for additional stone procedures.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with urolithiasis and choose to have ESWL treatment
- •Age 18-90 years old
- •Able to understand the informed consent
排除标准
- •Cognitively impaired
研究组 & 干预措施
Using HM3 lithotripter
This is an older generation lithotripter
干预措施: Extracorporeal Shock Wave Lithotripsy (ESWL) (Procedure)
F2 lithotripter
This is a newer generation lithotripter
干预措施: Extracorporeal Shock Wave Lithotripsy (ESWL) (Procedure)
结局指标
主要结局
Stone free rate, complications and need for ancillary procedures
时间窗: 3-5 years
次要结局
未报告次要终点