Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Effectiveness - Volume of Fragments < 2 mm
研究概览
简要总结
Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.
详细描述
This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology Clinic.
The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤ 12 mm.
The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as:
- 350 kil0Hertz (kHz) acoustic frequency
- 7 MegaPascals (MPa) peak negative pressure
- 20 cycle pulse duration
- 17 Hz pulse repetition frequency
A maximum of 3 stones can be treated per subject.
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
盲法说明
Some outcomes assessors will be blinded to the treatment conditions. This will include review of video data for tissue injury.
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
- •Individuals scheduled for clinical stone removal via ureteroscopy (URS)
排除标准
- •Individuals under 18 years of age
- •Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.)
- •Individuals with uncorrected bleeding disorders or coagulopathies
- •Individuals taking a clinically significant anticoagulant dose at the time of the procedure
- •Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm
- •Individuals with a solitary kidney
- •Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure
研究组 & 干预措施
Treatment Group
Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.
干预措施: Burst Wave Lithotripsy (Device)
结局指标
主要结局
Effectiveness - Volume of Fragments < 2 mm
时间窗: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.
Safety - Area of Tissue Injury
时间窗: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
次要结局
- Safety - Adverse Event Assessment(out to 120 days post-procedure)
- Effectiveness - Time to Full Comminution(Day 0 - the day of the experimental procedure immediately following the acoustic procedure.)
研究者
Jonathan Harper, MD
Adjunct Professor, Surgery
University of Washington