Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 19
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones.
Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.
详细描述
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be >4millimeter (mm) to 10 mm in size.
Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.
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
- •Subjects presenting with at least one stone apparent on radiographic imaging.
- •Target stone must be within the upper urinary tract.
- •Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
- •Target stone size is > 4 mm and ≤ 10 mm.
- •Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
- •Target stone can be individually visualized from other stones.
排除标准
- •Subject has an acute untreated urinary tract infection or urosepsis.
- •Subject has an uncorrected bleeding disorder or coagulation abnormality.
- •Subject is confirmed to be or suspected to be pregnant.
- •Subject has a urinary tract obstruction distal to the stone.
- •Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
- •Subject has stones that are not echogenically visible with ultrasound.
- •Subject belongs to a vulnerable group (prisoner, etc.).
- •Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
- •Subject is under 18 years of age.
- •Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
- •Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
- •Subject has a solitary kidney.
- •Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
- •Subject is unable to read or comprehend the consent form.
研究组 & 干预措施
Break Wave™ Procedure
The subject will undergo the Break Wave procedure.
干预措施: Break Wave extracorporeal lithotripsy (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 10 +/- 2 weeks post final Break Wave procedure
Proportion of subjects with a radiographic assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (≤ 4 mm).
Primary Safety Endpoint
时间窗: During procedure and through 90 days post-procedure
Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia
次要结局
- Secondary safety endpoint(During procedure and through 90 days post-procedure)