Ultrasound Instrument to Prevent Dialysis Graft Failure

预防透析移植失败的超声波仪器

• 批准号: 6887030
• 负责人: David Vilkomerson
• 金额: $ 61.68万
• 依托单位: DVX, LLC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-01 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6887030
• 关键词: bioimaging /biomedical imaging; clinical research; dialysis; hemodynamics; human subject; patient oriented research; portable biomedical equipment; statistics /biometry; technology /technique development; transplant rejection; ultrasound blood flow measurement

DESCRIPTION (provided by applicant): The aim of this program is to develop and bring to commercialization a new ultrasound Doppler device to be used to monitor the flow in dialysis access grafts. By detecting falling flow before the graft thromboses, this instrument can significantly reduce the $1 billion and thousands of days of hospitalization now caused by these graft failures. In a small group of dialysis patients, a research version of this device has been shown to be accurate while quickly measuring graft flow, and, because of its unique automatic operation, has been used by non-specialists. Because of its low cost, ease-of-use, and speed, weekly measurements of graft flow are practical, rather than the monthly intervals that other systems have required. Additionally, because the ultrasound Doppler instrument is used before the patient is connected to the dialysis machine, it is not affected by the hemodynamic changes caused by hemodialysis, nor does it interrupt the dialysis procedure, unlike other systems that have been used up to now. In this Fast Track Proposal, Phase I will validate the instrument's sensitivity and specificity in a statistically significant sized group, and test the operator-independence of the measurement. If the instrument meets the goals set in Phase I, Phase II will establish a randomized, controlled clinical trial, comparing a control group having usual care with a matched experimental group being monitored weekly with the new device. Total medical costs and hospitalization associated with the two groups will be captured and compared, with the hypothesis being tested that the monitored group will show significantly reduced access-related costs and improved quality of life, as measured by hospitalization. During Phase I and II, the research instrument will be redesigned as a small, portable unit with a PDA as the interface to the user. Production prototypes will be ready by the end of Phase II so that commercialization will be able to proceed quickly.

描述（由申请人提供）： 该计划的目的是开发一种新的超声多普勒设备并将其商业化，用于监测透析通路移植物的流量。通过在移植物血栓形成之前检测流量下降，该仪器可以显着减少目前因这些移植物失败而导致的 10 亿美元和数千天的住院时间。在一小群透析患者中​​，该设备的研究版本已被证明在快速测量移植流量时是准确的，并且由于其独特的自动操作，已被非专家使用。由于其成本低、易于使用且速度快，每周测量移植物流量是实用的，而不是其他系统所要求的每月一次。此外，由于超声多普勒仪器是在患者连接到透析机之前使用的，因此与迄今为止使用的其他系统不同，它不会受到血液透析引起的血流动力学变化的影响，也不会中断透析过程。在此快速通道提案中，第一阶段将在统计上显着的规模组中验证仪器的灵敏度和特异性，并测试测量的操作员独立性。如果该仪器达到第一阶段设定的目标，第二阶段将建立一项随机对照临床试验，将接受常规护理的对照组与每周使用新设备监测的匹配实验组进行比较。将捕获并比较与两组相关的总医疗费用和住院费用，并测试假设，即根据住院费用衡量，受监测组将显示出显着降低的与获取相关的费用和改善的生活质量。在第一阶段和第二阶段，研究仪器将被重新设计为小型便携式装置，并以 PDA 作为用户界面。生产原型将在第二阶段结束时准备就绪，以便商业化能够快速进行。