A NEW SYSTEM FOR ULTRASONIC ASSESSMENT OF THE CALCANEUS

跟骨超声评估的新系统

基本信息

批准号：
8882870
负责人：
Jonathan Kaufman
金额：
$ 43.22万
依托单位：
CYBERLOGIC, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-01 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8882870
关键词：
Age Age-Years American Architecture Bone Density Clinical Clinical Data Clinical Management Data Detection Development Devices Disease Distal Dual-Energy X-Ray Absorptiometry Early Diagnosis Early treatment Effectiveness Elderly Electromagnetic Energy Employee Strikes Forearm Fostering Foundations Fracture Goals Gold Health Health Care Costs Heel Heterogeneity Hip Fractures Individual Ionizing radiation Laboratories Lead Legal patent Length Measurement Measures Mechanics Metabolic Bone Diseases Methods Multivariate Analysis Osteoporosis Patients Performance Phase Positioning Attribute Public Health Relative (related person)Reproducibility Research Risk Risk Assessment Roentgen Rays Safety Small Business Innovation Research Grant Spinal Fractures System Techniques Technology Testing Tissues Ultrasonics Ultrasonography base bone bone mass bone strength calcaneum cost design foot improved instrument interest novel novel strategies primary care setting programs prototype research clinical testing screening success tool wrist fracture

项目摘要

DESCRIPTION (provided by applicant): This Lab to Marketplace SBIR Phase I Phase II Fast Track Application has as its long- term objective to establish ultrasound as a safe, effective, and non-invasive method for assessing fracture risk, an important component in clinical management of osteoporosis. Osteoporosis afflicts over 20 million people in the U.S., and is responsible for more than 275,000 hip fractures annually. Currently, the primary means for assessment relies on densitometric techniques. These methods subject the patient to ionizing radiation, are relatively expensive, and do not always provide good estimates of bone strength. Ultrasound offers several potential advantages. It is non- ionizing and relatively inexpensive. Moreover, since ultrasound is a mechanical wave and interacts with bone in a fundamentally different manner than electromagnetic radiation, it may ultimately be able to provide more accurate estimates of bone strength and fracture risk compared with current densitometric methods. The goal of this research is to develop a new ultrasound system for bone assessment that is not only accurate but also highly reproducible. The system will assess the heel bone (calcaneus) distal forearm employ a novel positioning device that is foot-size based. The technology is designed to achieve both high reproducibility, as well as analogous regions of interest among different individuals to be compared. This is crucial given the high degree of heterogeneity that exists in the calcaneus. This research should enable the widespread detection of osteoporosis and fracture risk, and will find application not only in the U.S. but worldwide as well. The specific aims of this Lab to Marketplace Fast Track SBIR Application are to demonstrate the feasibility of a novel positioning device which in conjunction with CyberLogic's NTD technology to accurately and reproducibly estimate BMD at the calcaneus. This will be achieved by clinical testing in Phase I using a laboratory prototype that incorporates the patented positioning technology. This will if successful, be followed by fabrication of a clinical device in the first year of Phase II, followed by 24 months of extensive Phase II clinical testing, which will include comparison of ultrasound data in subjects with and without fragility fractures. Finally, the last year of Phase II will include submission to FDA of a 510(k) application. The ultimate goal of this research is to commercialize this novel heel ultrasound device and to bring it into worldwide use for a simple, safe and effective instrument for bone density estimation and fracture risk assessment.

描述（由申请人提供）：该实验室到市场SBIR I期II期快速应用程序的长期目标是将超声确定为安全，有效，并且评估骨折风险的非侵入性方法，这是骨质疏松症临床管理中的重要组成部分。在美国，骨质疏松症折磨了超过2000万人，每年造成275,000多个髋部骨折。当前，评估的主要手段依赖于光密度计。这些方法使患者接受电离辐射，相对昂贵，并且并不总是提供良好的骨骼强度估计。超声波提供了几种潜在的优势。它是不可电离且相对便宜的。此外，由于超声是机械波，并且与电磁辐射的根本不同方式与骨相互作用，因此与当前的密度测定方法相比，它最终可以提供更准确的骨强度和断裂风险的估计。这项研究的目的是开发一种用于骨骼评估的新超声系统，该系统不仅准确，而且高度可重复。该系统将评估脚跟骨（Colcaneus）远端前臂采用基于脚尺寸的新型定位装置。该技术旨在实现高可重现性，以及要比较不同个体的类似区域。鉴于卡内斯中存在的高度异质性，这至关重要。这项研究应该使骨质疏松症和骨折风险的广泛检测能够广泛检测，并且不仅在美国，而且还将在全球范围内找到应用。该实验室对市场快速SBIR应用的具体目的是证明一种新型定位设备的可行性，该设备与Cyberlogic的NTD技术结合使用，以准确且可重复地估计Calcaneus的BMD。这将通过I阶段的临床测试实现，使用实验室原型获得专利的定位技术。如果成功的话，将在第二阶段的第一年进行制造，然后在24个月的II期临床上进行24个月测试将包括在有或没有脆弱性骨折的受试者中比较超声数据。最后，第二阶段的最后一年将包括提交510（k）申请的FDA。这项研究的最终目标是将这种新颖的高跟鞋超声设备商业化，并将其用于全球使用，以进行简单，安全和有效的工具，以进行骨密度估计和断裂风险评估。