Sedationless Multi-View High-Resolution Endoscopy

无镇静多视角高分辨率内窥镜检查

• 批准号: 10669811
• 负责人: Bhaskar Banerjee
• 金额: $ 91.8万
• 依托单位: OMNISCIENT IMAGING, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10669811
• 关键词: Address; Anesthesia procedures; Barrett Esophagus; Biopsy; Chronic; Client satisfaction; Clinical; Clinical Research; Collaborations; Complication; Consultations; Dedications; Deglutition; Detection; Development; Devices; Diagnosis; Diameter; Disease; Disinfection; Duodenal Diseases; Duodenum; Electronics; Endoscopes; Endoscopy; Esophageal Diseases; Esophageal Varix; Esophagitis; Esophagogastric Junction; Esophagus; Evaluation; Food; Gastroenterologist; Gastroesophageal reflux disease; Hand; Human Resources; Image; Imaging Device; Light; Lighting; Malignant Neoplasms; Malignant Squamous Cell Neoplasm; Malignant neoplasm of esophagus; Marketing; Organ; Patients; Peptic Esophagitis; Persons; Pharmaceutical Preparations; Phase; Physicians; Positioning Attribute; Predictive Value; Preparation; Procedures; Protocols documentation; Recommendation; Reflux; Research; Research Personnel; Resolution; Risk; Rotation; Safety; Sales; Sedation procedure; Specificity; Stomach; Stomach Diseases; Symptoms; System; Testing; Traction; United States Food and Drug Administration; Validation; Visual; Visualization software; Work; capsule; chromoscopy; chronic liver disease; cost; cost effective; design; gastric fundus; gastrointestinal; health care disparity; high resolution imaging; imaging capabilities; improved; meetings; point of care; prevent; research clinical testing; safety testing; screening; sensor; tool; verification and validation; wireless

Abstract An upper endoscope is designed for the endoscopic evaluation of the esophagus, stomach and duodenum, however, of the six-million upper endoscopies performed annually in the US, about half are for the disorders of the esophagus alone, where it can be argued that a full endoscopy of these three organs is not necessary in many, particularly since the procedure requires sedation with its associated risk and expense. Sedation adds to the risk of complications and increases expense. The high cost also adds to healthcare disparities. We propose a safer, cost-effective and convenient alternative by developing a market-ready high- resolution endoscopic tool that will allow patients to have an un-sedated inspection of the esophagus, affordably and in the convenience of their doctor’s office. Our device would be most effective in the evaluation of patients with gastro-esophageal reflux symptoms and to screen for its complication, Barrett’s esophagus, both of which are highly prevalent. Since Barrett’s esophagus is found in about 15% of patients with chronic reflux symptoms, visually confirming its absence will allow 85% of patients to avoid a standard endoscopy with biopsies which would be needed for only 15% of patients. It will also allow screening for esophageal varices in patients with chronic liver disease and allow widespread affordable screening for squamous cell cancer in other parts of the world. We have developed a reusable tethered capsule with a forward- and rear- facing cameras, capable of white- light and narrow-band imaging with a degree of resolution beyond the reach of current endoscopes. The compact capsule is smaller than current wireless capsules and was developed after consultations with physicians, marketing and sales personnel in endoscopy. Development was guided by meetings with the FDA, which recommended that we proceed with bench tests followed by a clinical evaluation. The clinical study will be led by an expert researcher in esophageal disease and endoscopy. We are collaborating with a marketing group known for successfully launching gastrointestinal endoscopic devices in the US and overseas. Our reusable high-resolution imaging device will allow the esophagus and proximal stomach to be examined easily, safely and affordably (at a fraction of the cost of a standard upper endoscopy) for a transformational effect on endoscopic practice. It will help detect common diseases in more people, prevent cancer and save lives.

抽象的 上内窥镜设计用于对食道、胃进行内窥镜评估 然而，在美国每年进行的 600 万例上消化道内窥镜检查中， 大约一半是单独的食道疾病，可以说，完整的食道疾病 对许多人来说，这三个器官的内窥镜检查是不必要的，特别是因为该手术 需要镇静剂及其相关的风险和费用。镇静剂会增加以下风险 并发症并增加费用。高昂的费用也加剧了医疗保健的差距。我们 通过开发市场就绪的高 分辨率内窥镜工具，使患者能够在不镇静的情况下进行检查 食道，价格实惠且方便，可以在医生办公室进行。 我们的设备在评估胃食管反流患者方面最为有效 症状并筛查其并发症（巴雷特食管），这两种疾病的发生率都很高 流行。由于约 15% 的慢性反流患者存在巴雷特食管 症状，目视确认其不存在将使 85% 的患者避免标准 只有 15% 的患者需要进行内窥镜活检。它还将允许 对慢性肝病患者进行食管静脉曲张筛查，并允许广泛开展 在世界其他地区提供负担得起的鳞状细胞癌筛查。 我们开发了一种可重复使用的系留胶囊，带有前置和后置摄像头， 能够进行白光和窄带成像，分辨率超乎想象 目前的内窥镜。紧凑型胶囊比当前的无线胶囊更小， 是在与医生、营销和销售人员协商后开发的 内窥镜检查。开发是在与 FDA 的会议的指导下进行的，FDA 建议： 我们进行台架测试，然后进行临床评估。该临床研究将由 食管疾病和内窥镜专家研究员。我们正在与一个合作 以在美国成功推出胃肠内窥镜设备而闻名的营销集团 美国和海外。我们的可重复使用的高分辨率成像设备将允许食道和 可以轻松、安全且经济地检查近端胃（费用仅为胃检查的一小部分） 标准上消化道内窥镜检查）对内窥镜实践产生变革性影响。这会有所帮助 发现更多人的常见疾病，预防癌症，挽救生命。