Development and Validation of NIRS-Based Sinusitis Screening

描述(由申请人提供)：在美国，慢性鼻窦炎与每年超过4000万次的医生和医疗保健提供者的就诊有关。鼻窦炎是根据临床病史诊断的，因此很难正确确定，因此误诊会导致过度治疗(即抗生素)和治疗不足(即误诊为过敏或偏头痛)。Praxis Biosciences，LLC的目标是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，适合初级保健医生和医生推广者使用。在这份提案中，我们将首先改进加州大学欧文分校贝克曼激光研究所开发的一种新型验证原型的设计，通过优化设备的外形因素、坚固性和光学设计。我们的设备基于近红外(NIR)转换照明的原理，但利用生物组织独特的近红外光学特性来产生更大的信号产量。在快速通道的第二阶段，我们将通过与耳鼻喉(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手段，然后监测初级保健环境中治疗的反应。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。 与公共卫生相关：在美国，慢性鼻窦炎每年影响约3200万人，其中1160万人去医生办公室就诊。目前初级保健环境中的诊断方法灵敏度相对较低，导致40%以上的假阴性结果。建议的产品基于近红外成像方法，将使初级医生能够简单快速地诊断鼻窦炎。

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.