Non-invasive Promotion of Clearance of Kidney Stones and Fragments

无创促进肾结石和碎片的清除

基本信息

批准号：
9144610
负责人：
Oren Levy
金额：
$ 73.69万
依托单位：
SONOMOTION, INC.
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-01 至 2018-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9144610
关键词：
Acoustics Affect American Animal Model Clinical Trials Custom Data Development Devices Diagnostic Documentation Economic Burden Effectiveness Emergency department visit Event FDA approved Family suidae Focus Groups Guidelines Health Heating Human Image In Vitro Individual Intervention Kidney Kidney Calculi Laser Lithotripsy Lead Lithotripsy Marketing Measurement Medical Methods Monitor Movement Operative Surgical Procedures Outcome Pain Patient observation Phase Physiologic pulse Procedures Production Radiation Recurrence Research Residual state Retreatment Safety Shipping Ships Shock Skin Surface System Technology Testing Time Ultrasonics Ultrasonography Ureter Urologic Diseases Urologist Urology Width base cost design effectiveness clinical trial imaging system improved in vivo interest meetings minimally invasive new technology phantom model prototype tool urolithiasis urologic usability

项目摘要

DESCRIPTION (provided by applicant): Kidney stones affect 1 in 11 Americans at an annual cost of $10B, with both numbers steadily climbing. Watchful waiting is the preferred approach to stone management, but there are no means to predict when the stone will pass or if the stone will pass. Intervention is typically recommended once a stone is over 5 mm and usually involves breaking the stone into smaller fragments, which are then expected to pass on their own. Multiple studies have shown that these residual fragments often do not pass on their own and lead to symptomatic stone events in up to 50%, and secondary surgery in 20%, of the 700,000 procedures performed yearly. A non-invasive tool that could facilitate stone fragment passage would significantly improve the management of kidney stones. Technology: Ultrasonic propulsion is a non-invasive tool to move stones within the collecting space using acoustic radiation force. The technology uses an existing commercial diagnostic probe so the stone movement can be monitored in real-time with imaging. The technology has the potential to aid in the passage of small stones and fragments in an office setting, improve stone free rates immediately following lithotripsy procedures, and relieve pain by moving a stone blocking the ureter. Preliminary Data: Investigational results from a feasibility trial has shown the technology to be safe and effective in humans with stone repositioning in 14 of 15 subjects and an aggregate 30 stone fragments passed by 4 of 6 post-lithotripsy subjects. Specific Aims: This is a Fast Track proposal that will use Phase 1 to test technical advances from which final design specifications will be formed for commercial prototype development in Phase 2. Phase 1 Aim 1 expands the capabilities of our technology, augmenting the Push pulse designed to move one stone at a time in order to collectively move a cluster of small stone fragments. A custom phantom model will be used to quantify improvement in the Push efficiency of a broadened beam relative to that of the existing narrow-beam system. The outcome will improve an operator's ability to clear the many small residual fragments found in post-lithotripsy subjects in a short timeframe. Phase 2 includes integrating imaging that tracks an acoustic signature unique to stones and assembling a focus group all to improve the usability of the system, porting the technology onto an FDA-approved, OEM, complete, urological ultrasound system, and performing the safety and effectiveness tests necessary for application for an investigational device exemption. The outcome of this proposal will be a clinical trial-ready, commercially viable ultrasonic propulsion and imaging system that can effectively treat post-lithotripsy stone fragments.

描述（由申请人提供）：肾结石影响十分之一的美国人，每年的费用为 $10B，这两个数字都在稳步上升，警惕等待是结石管理的首选方法，但没有办法预测结石何时会消失。或者，一旦结石超过 5 毫米，通常会建议进行干预，通常包括将结石破碎成较小的碎片，然后预计这些碎片会自行排出。在在每年进行的 700,000 例手术中，高达 50% 的患者会出现明显症状的结石事件，并导致 20% 的患者进行二次手术。一种可以促进结石碎片排出的非侵入性工具将改善肾结石的治疗。超声波推进是一种利用声辐射力在收集空间内移动结石的非侵入性工具，该技术使用现有的商用诊断探头，因此可以通过成像实时监测结石的移动。这在办公室环境中排出小结石和碎片，在碎石手术后立即提高结石清除率，并通过移动阻塞输尿管的结石来缓解疼痛。初步数据：可行性试验的研究结果表明了该技术。对 15 名受试者中的 14 名受试者进行结石重新定位，以及 6 名碎石术后受试者中的 4 名通过的总计 30 个结石碎片，对人类安全有效。具体目标：这是一项快速通道提案，将使用第一阶段来测试技术进步。最终设计规范将在第二阶段形成，用于商业原型开发。第一阶段目标 1 扩展了我们技术的能力，增强了旨在一次移动一块石头的推脉冲，以便集体移动一块石头。定制的模型模型将用于量化加宽光束相对于现有窄光束系统的推送效率的改进，结果将提高操作员清除发现的许多小残留碎片的能力。在碎石术后受试者中第二阶段包括集成跟踪结石特有的声学特征的成像，并组建焦点小组，以提高系统的可用性，将该技术移植到 FDA 批准的 OEM 完整泌尿超声系统上，并进行执行。申请研究设备豁免所需的安全性和有效性测试该提案的结果将是一种可进行临床试验、商业上可行的超声推进和成像系统，可以有效治疗碎石术后结石碎片。