Sedationless Multi-View High-Resolution Endoscopy

无镇静多视角高分辨率内窥镜检查

• 批准号: 10640358
• 负责人: Bhaskar Banerjee
• 金额: $ 103.17万
• 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/10640358
• 关键词: Address; Anesthesia procedures; Barrett Esophagus; Biopsy; Caliber; Chronic; Client satisfaction; Clinical; Clinical Research; Complication; Consultations; Custom; Deglutition; Detection; Development; Devices; Diagnosis; Disease; Disinfection; Duodenum; 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; Reflux; Research; Research Personnel; Resolution; Risk; Rotation; Safety; Sales; Sedation procedure; Sensitivity and Specificity; Stomach; Symptoms; System; Testing; Traction; United States Food and Drug Administration; Validation; Visual; 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; 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.

摘要 上内窥镜设计用于食管、胃和食管的内窥镜评价， 然而，在美国每年进行的600万例上消化道内窥镜检查中， 大约一半仅用于食道疾病，可以说，完整的食道疾病 这三个器官的内窥镜检查在许多情况下是不必要的，特别是因为 需要镇静剂并伴随着相关的风险和费用。镇静剂会增加 并发症和增加费用。高成本也加剧了医疗保健的不平等。我们 通过开发一种市场上现成的高效率、低成本和方便的替代品，提出一种更安全、更具成本效益和方便的替代品， 分辨率内窥镜工具，将允许患者有一个非镇静检查的 食道，经济实惠，方便他们的医生的办公室。 我们的设备将是最有效的评价患者的胃食管反流 症状，并筛选其并发症，巴雷特食管，这两个都是高度 普遍存在。由于巴雷特食管是发现在约15%的患者慢性反流 症状，视觉确认其不存在将允许85%的患者避免标准 只有15%的患者需要内窥镜检查和活检。它还将允许 筛查慢性肝病患者的食管静脉曲张，并允许广泛的 在世界其他地区进行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带前后摄像头的太空舱， 能够进行白色光和窄带成像，其分辨率超出了 当前的内窥镜。紧凑型胶囊比目前的无线胶囊更小， 是在与医生、市场营销人员和销售人员协商后制定的， 内镜与FDA的会议指导了开发工作，会议建议， 我们进行了台架测试，然后进行了临床评估。临床研究将由以下人员领导： 食管疾病和内窥镜检查方面的专家研究员。我们正在与一个 以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 近端胃检查容易，安全和经济实惠（在成本的一小部分， 标准上消化道内窥镜检查），以实现对内窥镜检查实践的变革。它将帮助 检测更多人的常见疾病，预防癌症，挽救生命。