Novel medical device for treatment of fungal nail infection

 描述(由申请人提供)：这项提案继续开发和测试一种新的、安全和有效的甲真菌病(指甲真菌感染)治疗设备。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，这些微生物可能会导致重大的医疗问题，包括蜂窝组织炎、皮肤溃疡和坏疽。超过3800万美国人患有甲真菌病，在美国医疗体系中，这种疾病的直接成本超过40亿美元。不同于目前可能导致肝脏损伤的口服疗法，或疗效较低或未经证实的局部乳膏和激光，这项赠款中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，而不会产生毒副作用。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，以证明使用我们的医疗设备原型治疗真菌感染的临床可行性。我们这个第二阶段项目的关键成功指标是真菌学治愈(即100%杀死真菌)和甲真菌病患者的指甲生长明显。在FDA批准的治疗甲真菌病的医疗设备的最终开发中，这是降低技术风险的必要步骤。为了支持我们的产品目标，我们建议回答与这种新型设备的实用性相关的四个关键问题：1)这三种临床仪器是否通过验证测试，以显示一致和相似的性能？2)该仪器在临床环境中是否可以根据用户说明、用户界面和人为因素分析发挥作用？3)一周内执行三种治疗方案是否会导致患者在真菌学上治愈？4)治疗是否会在6个月的间隔内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?