Sedationless Multi-View High-Resolution Endoscopy

无镇静多视角高分辨率内窥镜检查

• 批准号: 10330394
• 负责人: Bhaskar Banerjee
• 金额: $ 39.64万
• 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 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10330394
• 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; 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; Wireless Technology; 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

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 设计了一种上部内窥镜，用于对食道、胃进行内窥镜检查 然而，在美国每年进行的600万例上消化道内窥镜检查中， 大约一半是针对食道疾病，在那里可以辩称，一个完整的 在许多情况下，这三个器官的内窥镜检查是不必要的，特别是在手术后 需要镇静剂及其相关的风险和费用。镇静剂增加了患上 使问题复杂化，增加费用。高昂的成本还加剧了医疗保健方面的差距。我们 通过开发面向市场的高性价比 分辨率内窥镜工具，将允许患者进行非镇静剂检查 食道，负担得起，而且在他们的医生办公室的便利。 我们的设备在评估胃食道反流患者方面将是最有效的 症状和并发症的筛查，巴雷特的食道，这两个都是高度 很流行。由于大约15%的慢性反流患者存在巴雷特食道 症状，视觉上确认它的存在将允许85%的患者避免标准 只有15%的患者需要内窥镜和活组织检查。它还将允许 筛查慢性肝病患者的食道静脉曲张 在世界其他地区进行负担得起的鳞状细胞癌筛查。 我们已经开发了一种可重复使用的系留太空舱，带有前后摄像头， 能够进行白光和窄带成像，分辨率超出可及范围 目前的内窥镜。该紧凑型胶囊比目前的无线胶囊小， 是在与医生、市场营销和销售人员协商后开发的 内窥镜检查。开发是通过与FDA的会议进行指导的，FDA建议 我们继续进行试验台测试，然后进行临床评估。这项临床研究将由 食道疾病和内窥镜方面的专家研究员。我们正在与一家 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 近端胃检查简单、安全、经济实惠(费用仅为 标准上内窥镜检查)，以实现内窥镜检查实践的变革效果。这会有帮助的 检测更多人的常见病，预防癌症，拯救生命。