A NEW SYSTEM FOR ULTRASONIC ASSESSMENT OF THE CALCANEUS

跟骨超声评估的新系统

• 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
• 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

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）：该实验室将 SBIR 阶段 I 阶段 II 快速通道应用推向市场，其长期目标是将超声波建立为一种安全、有效和可靠的方法。 评估骨折风险的非侵入性方法，是骨质疏松症临床管理的重要组成部分。在美国，骨质疏松症困扰着超过 2000 万人，每年造成超过 275,000 例髋部骨折。目前，评估的主要手段依赖于光密度技术。这些方法使患者受到电离辐射，相对昂贵，并且并不总能提供良好的骨强度估计。超声波具有多种潜在优势。它是非电离的并且相对便宜。此外，由于超声波是一种机械波，并且以与电磁辐射根本不同的方式与骨骼相互作用，因此与当前的密度测量方法相比，它最终可能能够提供更准确的骨骼强度和骨折风险估计。这项研究的目标是开发一种用于骨骼评估的新型超声系统，该系统不仅准确而且具有高度可重复性。该系统将采用基于足部尺寸的新型定位装置来评估前臂远端跟骨（跟骨）。该技术旨在实现高再现性以及不同个体之间相似的感兴趣区域进行比较。考虑到跟骨中存在高度的异质性，这一点至关重要。这项研究应该能够广泛检测骨质疏松症和骨折风险，并将不仅在美国而且在全世界得到应用。该实验室向市场快速推出 SBIR 应用程序的具体目标是展示新型定位设备的可行性，该设备与 Cyber​​Logic 的 NTD 技术相结合，可准确且可重复地估计跟骨处的 BMD。这将通过使用实验室原型进行第一阶段的临床测试来实现，该原型包含 专利定位技术。如果成功，将在 II 期的第一年制造临床设备，然后进行 24 个月的广泛 II 期临床 测试，其中包括比较患有和不患有脆性骨折的受试者的超声数据。最后，第二阶段的最后一年将包括向 FDA 提交 510(k) 申请。这项研究的最终目标是将这种新型足跟超声设备商业化，并将其推向全球，成为一种简单、安全、有效的骨密度估计和骨折风险评估仪器。