Dual View Endoscopy for Colonoscopy

用于结肠镜检查的双视图内窥镜检查

• 批准号: 9789194
• 负责人: Bhaskar Banerjee
• 金额: $ 111.7万
• 依托单位: OMNISCIENT IMAGING, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9789194
• 关键词: Arizona; Caliber; Clinical Trials; Collaborations; Colon; Colon Carcinoma; Colonoscopes; Colonoscopy; Computer software; Custom; Detection; Development; Device or Instrument Development; Devices; Disinfection; Distal; Early Diagnosis; Endoscopes; Endoscopy; Expenditure; Family suidae; Feedback; Gastroenterologist; Goals; Grant; Human; Image; Industry; International; Lead; Legal patent; Lesion; Lighting; Link; Malignant Neoplasms; Market Research; Marketing; Medical Device; Methods; Mind; Monitor; Neoplasms; Optics; Performance; Phase; Polyps; Positioning Attribute; Precancerous Polyp; Premalignant; Procedures; Research; Research Proposals; Resolution; Safety; Scientist; Screening procedure; Small Business Technology Transfer Research; System; Techniques; Technology; Testing; Thumb structure; Tissues; United States Food and Drug Administration; Universities; Vision; biomaterial compatibility; capsule; clinical implementation; colon cancer prevention; colon cancer screening; cost; cost effective; design; flexibility; imaging system; improved; in vivo; industry partner; lens; miniaturize; models and simulation; multidisciplinary; off-patent; phase 1 study; prevent; product development; prototype; sensor

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.

摘要（ ( 然而，在美国，每年估计进行1600万次结肠镜检查，费用约为240亿美元。 目前具有前视的结肠镜不能检测到25-40%的癌前息肉。超过70%的 遗漏的息肉位于结肠的许多褶皱上或后面， 前视结肠镜在本研究提案中，我们建议完成成像的开发 该系统在一张图像中提供了前所未有的正向和360度反向视图。在我们 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 我们的双视图技术优于标准结肠镜检查。这项技术是由联合国发明的， 该公司的创始人，亚利桑那大学的胃肠病学家和光学科学家， 由全知科技授权器械开发由内窥镜医师和行业的反馈指导 高管在这项提案中，我们将进一步简化设备，提高分辨率，并建立一个成像 该系统可以与任何商业内窥镜平台集成。我们的市场调查显示， 对可以与现有内窥镜结合使用的“附加装置”的压倒性需求，而不是 全新的内窥镜与亚利桑那大学合作，全知将开发一种成像技术， 其中直径约为4 mm的胶囊可以附接到任何现有结肠镜的尖端 为内窥镜医生提供前所未有的前向和360度后向视图， 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，使我们的产品具有很高的成本效益，并允许内窥镜医生继续使用他们的 首选内窥镜。我们已经组建了一个多学科的团队，并与业界建立了合作关系。 透镜制造、照相机制造和医疗设备营销方面的合作伙伴，以促进 我们产品的开发和市场投放。我们将继续利用终端使用和市场反馈，以精细化- 在遵循监管标准的同时调整该成像系统的开发。全知科技联系了 美国食品和药物管理局，并将完成在猪体内结肠镜检查研究，以及 监管批准所需的可再加工性测试。在这项研究的后期阶段，该公司将 开始组织多中心人体研究，这些研究应导致产品在监管批准后上市。 我们非凡的技术将改变结肠镜检查的方式。这将大大提高息肉 这将有助于提高结肠镜检查的准确性，预防更多的癌症，并减少国家在结肠镜检查方面的支出。