Development and Validation of NIRS-Based Sinusitis Screening

基于 NIRS 的鼻窦炎筛查的开发和验证

• 批准号: 8201238
• 负责人: Joon You
• 金额: $ 16.05万
• 依托单位: PRAXIS BIOSCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-07 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8201238
• 关键词: Accounting; Acute; Affect; Algorithms; Antibiotics; Chronic; Chronic Sinusitis; Clinical; Clinical Research; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Ear; Effectiveness; Feedback; Funding; Health Care Costs; Health Personnel; Human Volunteers; Hypersensitivity; Image; Imaging Device; Institutes; Lasers; Life; Lighting; Marketing; Migraine; Monitor; Negative Finding; Nose; Operative Surgical Procedures; Optics; Otolaryngologist; Output; Patients; Persons; Pharyngeal structure; Phase; Physician Assistants; Physicians; Physicians' Offices; Pilot Projects; Primary Care Physician; Primary Health Care; Property; Recording of previous events; Screening procedure; Signal Transduction; Sinus; Sinusitis; Software Design; Specialist; Specific qualifier value; Staging; Standardization; System; Testing; Tissues; Validation; Visit; X-Ray Computed Tomography; base; cohort; cost; design; ergonomics; imaging modality; improved; meetings; novel; optical imaging; primary care setting; prototype; response; tool; volunteer

DESCRIPTION (provided by applicant): In the U.S., chronic sinusits is associated with over 40 million visits to physicians and health care providers each year. Sinusitis is diagnosed based on clinical history which is difficult to correctly ascertain, and hence misdiagnosis leads to both over-treatment (i.e. antibiotics) and under-treatment (i.e. misdiagnosis as allergies or migraine). Praxis Biosciences, LLC aims to develop and deliver a very low-cost optical imaging tool for quick and simple assessment of sinusitis suitable for use by both primary care doctors and physician extenders. In this proposal, we will first improve on the design of a novel validated prototype developed at the Beckman Laser Institute at UC Irvine by optimizing device form factor, robustness, and optical design. Our device is based upon the principles of near-infrared (NIR) trans-illumination but exploits the unique near infrared optical properties of living tissue to generate substantially greater signal yield. In the second phase of the fast-track, we will validate its efficacy of this market-ready optimized device via a clinical study with Ear, Nose & Throat (ENT) specialists and primary care physicians. The proposed low-cost optical imaging tool will be able to provide means to better identify patients with acute sinusitis and then monitor the response to therapy in primary care settings. Ultimately, our device will help reduce the health-care costs related by optimizing and streamlining diagnosis and treatment. PUBLIC HEALTH RELEVANCE: In the US, chronic sinusitis affects approximately 32 million persons each year and accounts for 11.6 million visits to physicians' offices. Current diagnostic methods in primary care settings suffer from relatively low sensitivity and leads to over 40% of false negative findings. The proposed product based on NIRS imaging method will enable primary physicians to make simple and quick diagnosis of sinusitis.

描述（由申请人提供）：在美国，慢性鼻窦炎与每年超过4000万次的医生和卫生保健提供者就诊有关。鼻窦炎的诊断是基于临床病史，这是很难正确确定的，因此误诊导致过度治疗（即抗生素）和治疗不足（即误诊为过敏或偏头痛）。Praxis Biosciences，LLC旨在开发和提供一种非常低成本的光学成像工具，用于快速简单地评估鼻窦炎，适用于初级保健医生和医生扩展器。在本提案中，我们将首先通过优化设备形状因子、稳健性和光学设计来改进加州大学欧文分校贝克曼激光研究所开发的新型经验证原型的设计。我们的设备基于近红外（NIR）透射照明的原理，但利用活组织的独特近红外光学特性来产生更大的信号输出。在快速通道的第二阶段，我们将通过与耳鼻喉科（ENT）专家和初级保健医生进行的临床研究来验证这种市场就绪的优化设备的有效性。拟议的低成本光学成像工具将能够提供更好地识别急性鼻窦炎患者的方法，然后在初级保健环境中监测对治疗的反应。最终，我们的设备将通过优化和简化诊断和治疗来帮助降低相关的医疗成本。 公共卫生关系：在美国，慢性鼻窦炎每年影响约3200万人，并占1160万次就诊。目前的诊断方法在初级保健设置遭受相对较低的灵敏度，并导致超过40%的假阴性结果。基于NIRS成像方法的申报产品将使初级医生能够简单快速地诊断鼻窦炎。