A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 12
- 主要终点
- Primary Effectiveness Outcome - Stone Fragmentation
研究概览
简要总结
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else.
Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.
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
- •Individuals presenting with at least one kidney stone apparent on CT.
- •Stones must be within the upper urinary tract.
- •Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
- •Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).
排除标准
- •Acute untreated urinary tract infection or urosepsis.
- •Uncorrected bleeding disorders or coagulopathies.
- •Pregnancy.
- •Uncorrected obstruction distal to the stone.
- •Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
- •Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
- •Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
- •Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
- •Individuals under 18 years of age.
- •Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
- •Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
- •Solitary kidney
- •Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
结局指标
主要结局
Primary Effectiveness Outcome - Stone Fragmentation
时间窗: 12 weeks post-treatment
Stone fragmentation as determined by stone passage or imaging confirmation.
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
时间窗: 12 weeks post-treatment
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
次要结局
- Secondary effectiveness outcome - Residual fragment size(12 weeks post-treatment)
- Secondary safety outcome - Adverse events(12 weeks post-treatment)
- Secondary effectiveness outcome - Stone Free Status(12 weeks post-treatment)