Economic spectroscopic evaluation of Cervical Cancer

宫颈癌的经济光谱评价

• 批准号: 7026614
• 负责人: Shabbir Bakir Bambot
• 金额: $ 100.32万
• 依托单位: GUIDED THERAPEUTICS
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-18 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7026614
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; cervix neoplasms; charge coupled device camera; clinical biomedical equipment; diagnosis quality /standard; fiber optics; fluorescence spectrometry; health economics; neoplasm /cancer diagnosis; noninvasive diagnosis; portable biomedical equipment; reflection spectrometry; spectrometry; women' s health

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. Early detection and diagnosis can saves lives and reduce the burden on the national healthcare system. We have built a non-invasive research-prototype point-of-care device to detect early cancerous conditions of the uterine cervix. We have tested this prototype in a multi-center national study accruing data from 600 women for training our algorithm. Through conversations with the FDA we now have in place a pivotal trial protocol for validating our algorithm. We will use a pre-production version of our device in this pivotal study. The pre-production device will be a cost and size reduced, portable, rugged and user-friendlier device and is intended to be identical to the device intended for sale without incurring the tooling costs necessary to enter the production phase. In Phase I of this fast track application we will address the high-risk aspects of building this pre-production device as well as arrive at a conceptual design. In Phase II we will finalize this design (both component level and systems integration) and build ten copies of the device to support the pivotal trial. We will also complete necessary systems tests and determine inter/intra device variability. We will conclude with the design documentation necessary for our PMA submission.

描述（由申请人提供）： 宫颈癌是全世界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。早期发现和诊断可以挽救生命并减轻国家医疗保健系统的负担。我们构建了一种非侵入性研究原型床旁设备来检测宫颈的早期癌变。我们在一项多中心国家研究中测试了这个原型，收集了 600 名女性的数据来​​训练我们的算法。通过与 FDA 的对话，我们现在已经制定了一个关键的试验方案来验证我们的算法。在这项关键研究中，我们将使用我们设备的预生产版本。预生产设备将是一种成本和尺寸降低、便携、坚固且用户友好的设备，并且旨在与打算销售的设备相同，而不会产生进入生产阶段所需的工具成本。在这个快速通道应用程序的第一阶段，我们将解决构建这个预生产设备的高风险方面，并达成概念设计。在第二阶段，我们将最终确定该设计（组件级和系统集成）并构建十个设备副本以支持关键试验。我们还将完成必要的系统测试并确定设备间/设备内的可变性。最后，我们将提供提交 PMA 所需的设计文档。