Novel medical device for treatment of fungal nail infection

 描述（由申请方提供）：本提案继续开发和测试一种新型、安全、有效的甲真菌病（指甲真菌感染）治疗器械。甲真菌病是一种常见的传染病，具有潜在的严重后果。受感染的指甲是微生物的持久储存库，可导致严重的医疗问题，包括蜂窝织炎，皮肤溃疡和坏疽。超过3800万美国人患有甲癣，在美国医疗保健系统中直接花费超过40亿美元。与目前可能导致肝损伤的口服治疗或疗效较低或未经证实的局部乳膏和激光不同，该补助金正在开发的设备为患者和医生提供了一种可靠，方便的方法来治疗指甲真菌感染，而没有毒副作用。在这个项目中，我们将在人类患者身上测试我们正在申请专利的技术，以证明用我们的医疗设备原型治疗真菌感染的临床可行性。我们对这个第二阶段项目的关键成功指标是真菌学治愈（即，100%真菌杀灭）和指甲生长清晰的甲真菌病患者。这是一个必要的步骤，以减少技术风险，在最终开发的FDA批准的医疗器械，用于治疗甲真菌病。为了支持我们的产品目标，我们建议回答与这种新型器械的实用性相关的四个关键问题：1）三种临床工具是否通过确认测试以显示一致和相似的性能？2）仪器在临床环境中是否与用户说明、用户界面和人为因素分析相关？3)在一周内执行三次治疗方案能否使患者获得真菌学治愈？; 4)在6个月的时间间隔内，治疗是否会使患者的指甲生长清晰？

 DESCRIPTION (provided by applicant): This proposal continues the development and testing of a novel, safe, and effective treatment device for onychomycosis (nail fungal infection). Onychomycosis is a common infectious disease with potentially serious consequences. The infected nail is a persistent reservoir for microbes that can lead to significant medical problems including cellulitis, skin ulceration, and gangrene. Over 38 million Americans suffer from onychomycosis, which carries a direct cost of over $4 billion in the US healthcare system. Unlike current oral treatments that may cause liver damage, or topical creams and lasers that have low or unproven efficacy, the device under development in this grant offers patients and doctors a reliable, convenient method to treat nail fungal infections without toxic side effects. I this project, we will test our patent-pending technology on human patients to prove the clinical feasibility of treating fungal infections with our medical device prototype. Our critical success metric for this Phase II project is mycological cure (i.e., 100% fungal killing) and clear nail growth in onychomycosis patients. This is a necessary step to reduce technical risk in the ultimate development of an FDA-approved medical device for curing onychomycosis. In support of our product goal, we propose to answer four critical questions related to the utility of this novel device: 1)Do the three clinical instruments pass validations testing to show consistent and similar performance?; 2)Is the instrument functional in a clinical setting as related to user instructions, user interface and human factor analysis?; 3) Can performing a three treatment protocol over a week result in mycological cure for the patient?; 4) Will the treatment result in clear nail growth for the patient over a 6-month interval?