Quantitative Optical Assessment of Middle Ear Disease

中耳疾病的定量光学评估

• 批准号: 8904538
• 负责人: Stephen A Boppart
• 金额: $ 80.35万
• 依托单位: PHOTONICARE, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8904538
• 关键词: 3-Dimensional; Accounting; Acute; Affect; Antibiotics; Biophotonics; Child; Chronic; Clinic; Clinical; Clinical Research; Data; Decision Making; Dependence; Detection; Devices; Diagnosis; Diagnostic; Disease; Disease Progression; Ear; Ear Diseases; Evaluation; Feasibility Studies; Feedback; Fever; General Population; Goals; Health; Health Care Costs; Healthcare Systems; Human; Image; Imaging Device; Imaging Techniques; Infection; Intervention; Lead; Liquid substance; Marketing; Measurement; Medical Device; Microbial Biofilms; Nose; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Otitis Media; Otitis Media with Effusion; Otolaryngologist; Otoscopes; Otoscopy; Outcome; Patients; Pharyngeal structure; Physician Assistants; Physicians; Primary Care Physician; Primary Health Care; Protocols documentation; Pus; Reader; Recurrence; Resolution; Savings; Severities; Specialist; Structure; Suppurative Otitis Media; Surface; Symptoms; System; Three-Dimensional Imaging; Time; Tissues; Training; Tympanic membrane; Unnecessary Surgery; Visit; Work; base; combat; commercial application; design; ear infection; effusion; illness length; imaging system; improved; instrument; middle ear; middle ear disorder; non-invasive imaging; optical imaging; primary care setting; profession allied to medicine; prototype; public health relevance; tool; treatment strategy

 DESCRIPTION (provided by applicant): PhotoniCare, Inc. is a medical device company developing a handheld, biophotonics imaging system suitable for use by otolaryngologists (ear, nose, and throat specialists; ENT) and primary care physicians (PCP) to enable real-time, 3-D assessment of sub-surface tissue structure in the middle ear. Significance: ENTs and PCPs have limited tools with which to diagnose otitis media (OM), or middle ear infections. OM affects the vast majority of children and accounts for more than 25 million annual physician visits. The current standard diagnostic tool for evaluating the middle ear, the otoscope, is a basic magnifier of tissue surfaces and has limited diagnostic ability and repeatability. The ability to provide physicians with unprecedented, quantitative information about the middle ear will reduce diagnostic variability between physicians and provide a more accurate picture of middle ear health to optimize treatment strategies. Hypothesis: The presence of middle ear biofilms or highly purulent effusions will be indicative of long-term chronic ear disease, even in patients tha are early in the disease cycle, providing an early indicator of long- term disease and a non-invasive, observable metric by using our device. Specific Aims: (1) Build a commercial prototype handheld OCT system designed for ENT specialists to non- invasively image through the eardrum and into the middle ear. (2) Conduct a 100-patient clinical utility study in ENT and primary care settings to determine the clinical value of quantifiable effusion purulence and presence of middle ear biofilms. (3) Conduct a 35-patient clinical utility study in the ENT clinic o determine dependence upon clinical expertise required to extract meaningful data from the imaging system. The long-term goal of this project is to better understand the impact of bacterial biofilms and effusion purulence on disease progression and treatment strategies. Commercial Opportunity: This device will provide physicians with new and quantitative information related to middle ear disease, enabling better decision-making for interventional surgery (more rapid intervention for children that need it and reduction of unnecessary surgeries). Reduction of even 5% of surgeries represents $150M in savings to the U.S. healthcare system each year. Additionally, the ability to shorten the cycle of repeat visits before surgery represents a large savings to payers and patients, alike.

 描述（由申请人提供）：PhotoniCare，Inc.是一家医疗设备公司，开发了一种手持式生物光子成像系统，适用于耳鼻喉科医生（耳鼻喉科专家; ENT）和初级保健医生（PCP），以实现对中耳表面下组织结构的实时3D评估。意义：耳鼻喉科和PCP诊断中耳炎（OM）或中耳感染的工具有限。OM影响着绝大多数儿童，每年有超过2500万人次的医生就诊。目前用于评估中耳的标准诊断工具耳镜是组织表面的基本放大镜，并且具有有限的诊断能力和可重复性。为医生提供前所未有的有关中耳的定量信息的能力将减少医生之间的诊断差异，并提供更准确的中耳健康状况，以优化治疗策略。假设：中耳生物膜或高度化脓性渗出液的存在将指示长期慢性耳部疾病，即使在疾病周期早期的患者中，通过使用我们的设备提供长期疾病的早期指示和非侵入性的可观察度量。具体目标：（1）建立为耳鼻喉科专家设计的商业原型手持式OCT系统，以通过鼓膜并进入中耳进行非侵入性成像。(2)在耳鼻喉科和初级保健环境中进行一项100例患者的临床效用研究，以确定可量化的积液化脓和中耳生物膜存在的临床价值。(3)在耳鼻喉科诊所进行一项35例患者的临床效用研究，以确定从成像系统中提取有意义数据所需的临床专业知识的依赖性。该项目的长期目标是更好地了解细菌生物膜和积液化脓对疾病进展和治疗策略的影响。商业机会：该设备将为医生提供与中耳疾病相关的新的定量信息，从而能够更好地决策介入手术（为需要的儿童提供更快速的干预并减少不必要的手术）。即使减少5%的手术，也意味着每年为美国医疗保健系统节省1.5亿美元。此外，能够缩短手术前重复就诊的周期，这对付款人和患者来说都是一笔巨大的节省。