Dual View Endoscopy for Colonoscopy

摘要( ( 然而，据估计，美国每年要进行1600万次结肠镜检查，费用约为240亿美元 目前的前视结肠镜无法发现25%-40%的癌前息肉。超过70%的 漏诊的息肉位于结肠中的许多皱折上或后面，在那里它们被隐藏起来，看不到 前视结肠镜。在这项研究计划中，我们建议完成我们的成像开发 该系统在一张图像中提供了前所未有的正视和360度反视。在我们的 STTR第一阶段研究，我们成功地开发了我们的第二个原型，并重新确认了实质性的 我们的双视图技术比标准结肠镜检查更具优势。这项技术是由合作伙伴发明的 该公司的创始人，亚利桑那大学的胃肠病专家和光学科学家， 得到了无所不知的授权。内窥镜专家和行业的反馈指导了设备的开发 高管们。在这项提议中，我们将进一步使设备微型化，提高分辨率，并建立成像 可与任何商业内窥镜检查平台集成的系统。我们的市场研究表明 迫切需要一种可以与现有内窥镜结合使用的“附加组件”，而不是 全新的内窥镜。与亚利桑那大学合作，全知科技将开发一种成像技术 直径约为4毫米的胶囊可以连接到任何现有结肠镜的尖端的系统 在单一显示器上为内窥镜医生提供前所未有的向前和360度向后视角 监视器。这种可重复使用的内窥镜附件将避免更换内窥镜的需要和费用 平台，使我们的产品具有极高的性价比，并允许内窥镜医生继续使用他们的 首选内窥镜检查。我们组建了一支多学科的团队，并与业界形成了合作 镜头制造、相机制造和医疗器械营销方面的合作伙伴，以促进成功 我们产品的开发和市场投放。我们将继续利用最终用途和市场反馈来细化- 在遵循监管标准的同时，调整此成像系统的开发。无所不知的已经联系了 美国食品和药物管理局将完成猪的体内结肠镜检查研究，以及 监管部门批准所需的再加工性测试。在本研究的后期阶段，该公司将 开始组织多中心人体研究，这些研究应导致在监管部门批准后推出产品。 我们非凡的技术将改变结肠镜检查的方式。它会大大增强息肉 检测，预防更多的癌症，减少国家结肠镜检查的支出。

Abstract( ( An estimated 16 million colonoscopies are performed annually in the US at a cost of about $24B, however current colonoscopes with forward vision fail to detect 25-40% of precancerous polyps. Over 70% of the missed polyps are located on or behind numerous folds in the colon where they are hidden from the sight of a forward-view colonoscope. In this research proposal, we propose to complete our development of an imaging system that provides unprecedented forward as well as 360-degree reverse views in a single image. In our STTR Phase I study, we successfully developed our second prototype and re-confirmed the substantial superiority of our Dual View technique over standard colonoscopy. The technology was invented by the co- founders of the company, a gastroenterologist and an optical scientist at the University of Arizona and has been licensed by Omniscient. Device development was guided by feedback from endoscopists and industry executives. In this proposal we will further miniaturize the device, improve resolution and build an imaging system that can be integrated with any commercial endoscopy platform. Our market research indicated an overwhelming need for an `add-on' that can be used in conjunction with existing endoscopes, rather than a totally new endoscope. In collaboration with the University of Arizona, Omniscient will develop an imaging system where a capsule with a diameter of about 4 mm can be attached to the tip of any existing colonoscope to provide endoscopists with unprecedented forward and 360-degree backwards views in a single display monitor. This reusable endoscopic accessory will avoid the need and expense of replacing an endoscopy platform, allow our product to be highly cost-effective and permit the endoscopist to continue to use their preferred endoscope. We have assembled a multi-disciplinary team and formed collaborations with industry partners in lens fabrication, camera manufacturing and medical device marketing to facilitate the successful development and market launch of our product. We will continue to use end-use and market feedback to fine- tune the development of this imaging system while following regulatory standards. Omniscient has contacted the US Food and Drug Administration and will complete in-vivo colonoscopy studies in pigs, as well as reprocessability tests needed for regulatory approval. In the latter stages of this research, the company will begin organizing multi-center human studies that should lead to product launch following regulatory approval. Our extraordinary technology will transform the way colonoscopy is performed. It will greatly enhance polyp detection, prevent more cancers and reduce the national expenditure for colonoscopy.