Multimodal Spectroscopic Evaluation of Cervical Cancer.

描述（由申请人提供）： 宫颈癌是世界范围内女性第二常见的癌症类型，也是发展中国家女性癌症相关死亡的主要原因。 我们开发了非侵入性的即时护理设备，以检测子宫颈的早期癌症状况。 在第一阶段资助的工作中，我们分析了早期原型获得的数据，以确定与诊断性能最相关的设备功能。 我们还将早期原型临床使用经验中发现的重要方面以及市场研究的反馈纳入设计器械中。 使用来自71名患者受试者的数据，我们继续显示出有希望的结果。 对于II期研究，我们提出了支持器械市场定位的器械声明，以及验证声明的全面数据累积和临床计划。 我们的第二阶段工作将以一项关键试验结束，其中包括我们验证设备的预生产版本和FDA PMA申请。

DESCRIPTION (provided by applicant): Cervical Cancer is the second most common type of cancer in women worldwide and the leading cause of cancer related mortality in women in developing countries. We have developed non-invasive point-of-care devices to detect early cancerous conditions of the uterine cervix. In a Phase I funded effort we analyzed data obtained with early prototypes to determine device features most relevant to diagnostic performance. We also incorporated into the design device aspects found to be important from our experience with the clinical use of the early prototypes as well as feedback from marketing studies. Using data from 71 patient subjects enrolled for preliminary testing with the validation device we continue to show promising results. For the phase II effort we have proposed device claims that support our market positioning of the device and a comprehensive data accrual and clinical plan to validate our claims. Our phase II effort will conclude with a pivotal trial that includes the pre-production version of our validation device and an FDA PMA application.