First-In-Human Feasibility Trial of Break Wave - The Office-Based Lithotripsy Solution

Break Wave 的首次人体可行性试验 - 基于办公室的碎石解决方案

• 批准号: 9919546
• 负责人: Oren Levy
• 金额: $ 99.72万
• 依托单位: SONOMOTION, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9919546
• 关键词: Accident and Emergency department; Acute; Address; Adverse event; Affect; Aftercare; American; Americas; Anesthesia procedures; Animals; Chronic; Clinic; Clinical; Clinical Trials; Consensus; Cost of Illness; Data; Device Designs; Devices; Diabetes Mellitus; Disease; Dose; Effectiveness; Elements; Emergency Department Physician; Emergency department visit; Ensure; Event; Extracorporeal Shockwave Lithotripsy; Family suidae; Feasibility Studies; Feedback; Fracture; Frequencies; Goals; Grant; Healthcare; Histologic; Human; Hypertension; Image; In Vitro; Injury; Injury to Kidney; Intervention; Kidney; Kidney Calculi; Laser Lithotripsy; Lithotripsy; Methods; Modeling; Modification; Movement; Natural graphite; Obesity; Operative Surgical Procedures; Outcome; Patients; Performance; Physiologic pulse; Population; Prevalence; Procedures; Protocols documentation; Risk; Safety; Shock; System; Techniques; Technology; Testing; Time; Ultrasonography; Update; Ureteroscopy; Urinary Calculi; Urologic Diseases; Urologist; Urology; Visit; Width; X-Ray Computed Tomography; arm; base; care burden; cost; design; feasibility trial; first-in-human; human subject; imaging system; improved; in vivo; low dose computed tomography; novel; open label; preclinical safety; preclinical study; preclinical trial; pressure; prospective; recruit; simulation; standard of care; verification and validation

Significance: There is a need for a safe and effective office-based lithotripsy treatment for kidney stones. Kidney stones are common; they affect nearly 10% of the US population and the prevalence continues to grow in parallel with diseases such as high blood pressure, diabetes, and obesity. Kidney stones are also one of the most costly urologic diseases in America; the health care burden in the US exceeds $10 billion annually. A substantial portion of this cost is due to the approximately one million surgical interventions and 20-40% rate of unplanned post-surgical events. This includes extracorporeal shock wave lithotripsy (SWL), a common noninvasive surgical intervention, and ureteroscopy laser lithotripsy (URS), a common endoscopic procedure. Both have a 5% or greater risk of significant adverse events and, in the US, both procedures are conducted within a surgical suite with the patient anesthetized. Technology: SonoMotion is developing an office-based, non-invasive, and anesthesia free stone lithotripsy solution for kidney and ureteral stones to redefine the standard of care for millions of people. Break WaveTM (i.e. BWL) is a novel method of stone fragmentation that uses multi-cycle, low-amplitude pulses of ultrasound rather than shock waves to induce stone fracture. This approach has the potential to reduce the risk of injury and the rate of procedural complications, as well as significantly lower procedural time and cost. Furthermore, the low amplitude pulses will preclude the need for anesthesia, providing an office-based treatment method. This could also potentially provide an attractive alternative to active surveillance of an obstructing stone. Preliminary Data: In vitro studies have shown the Break Wave technology is capable of fragmenting most common human stones into fragment sizes that are consistently less than 1 mm. Clinical simulation conducted in a porcine model indicates the pressure levels required to break stones are below the pressure levels required to induce renal injury. Specific Aims: Aim 1 is a 30-patient, prospective, open-label, multi-center, single-arm First-In-Human feasibility clinical trial to assess the safety and effectiveness of Break Wave. Subjects presenting with upper urinary tract stones will be recruited as an alternative to SWL. Effectiveness is to be determined by stone passage, post-treatment low dose CT imaging, and the need for secondary procedures; safety is to be evaluated through the documented occurrences of adverse events, post-procedural imaging, unplanned physician/ED visits. Procedural tolerance and effectiveness will also be evaluated at multiple pressure levels and at reduced to no anesthesia. The trial will be conducted across 4 centers to derive a broad range of feedback across multiple well-established urologists. Throughout the trial, SonoMotion will identify device design and procedural adjustments to improve safety and effectiveness, and implement those changes in Aim 2. Aim 2 will also implement and test expanding the beam width to break larger stones and accommodate greater patient movement. The outcome of this grant will be a clinical-ready system to initiate a pivotal clinical trial for FDA regulatory approval.

意义：需要一种安全有效的基于诊所的肾结石碎石治疗。 肾结石是常见的;他们影响近10%的美国人口和患病率继续增长 与高血压、糖尿病和肥胖症等疾病同时发生。肾结石的症状有哪些？ 美国最昂贵的泌尿系统疾病;美国的医疗保健负担每年超过100亿美元。一 该成本的很大一部分是由于大约一百万次手术干预和20-40%的 意外的术后事件这包括体外冲击波碎石术（SWL），一种常见的 非侵入性手术干预和输尿管镜激光碎石术（URS），一种常见的内窥镜手术。 两者都有5%或更高的重大不良事件的风险，在美国，这两种程序都进行 在手术室里，病人被麻醉了技术：SonoMotion正在开发一种基于办公室的， 无创、无麻醉的肾和输尿管结石碎石解决方案，重新定义 数百万人的护理标准。Break WaveTM（即BWL）是一种新的碎石方法， 使用多周期、低振幅的超声波脉冲而不是冲击波来诱导结石破裂。这 该入路有可能降低损伤风险和手术并发症发生率， 显著降低手术时间和成本。此外，低幅度脉冲将排除对 麻醉，提供基于办公室的治疗方法。这也可能提供一个有吸引力的 替代主动监视障碍物的方法初步数据：体外研究表明， 破碎波技术能够将大多数常见的人体结石破碎成 在猪模型中进行的临床模拟表明压力水平 所需的压力水平低于引起肾损伤所需的压力水平。具体目标：目标1 一项30例患者、前瞻性、开放标签、多中心、单组首次人体可行性临床试验，以评估 安全性和有效性。将招募上尿路结石受试者 作为SWL的替代品。有效性将通过结石通过、治疗后低剂量CT来确定 成像和二次手术的需要;通过记录的事件评价安全性 不良事件、术后成像、计划外医生/艾德访视。程序宽容和 还将在多个压力水平和减少至无麻醉下评价有效性。试验将 在4个中心进行，以获得多位知名泌尿科医生的广泛反馈。 在整个试验过程中，SonoMotion将确定器械设计和手术调整，以提高安全性， 并在目标2中实施这些更改。目标2还将实施和测试扩大光束 宽度，以打破更大的石头，并适应更大的病人运动。这笔赠款的结果将是一个 临床就绪系统，以启动FDA监管批准的关键临床试验。