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.
Public Health Relevance Statement: Project Narrative Upper endoscopy is a common procedure performed under sedation; however, it is unnecessary in patients requiring visual inspection of the esophagus. We will develop and test a market-ready tethered imaging capsule that can be used to view the esophagus and upper stomach in the doctor's office, safely without sedation, and with greater clarity than current endoscopes, but at a fraction of the cost of a traditional endoscopy. We will evaluate it by comparing it to upper endoscopy in patients with esophageal disorders and submit an application to the FDA for regulatory approval in preparation for market launch.
Project Terms: Anesthesia procedures; Anesthesia; Barrett Esophagus; Barrett Syndrome; Barrett Ulcer; Columnar Epithelial-Lined Lower Esophagus; Columnar-Lined Esophagus; esophageal intestinal metaplasia; Biopsy; Malignant Neoplasms; Cancers; Malignant Tumor; malignancy; neoplasm/cancer; capsule; Capsules; Clinical Research; Clinical Study; Complication; Consultations; Deglutition; Swallowing; Diagnosis; Disease; Disorder; Disinfection; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Duodenum; Endoscopes; Endoscopy; endoscopic imaging; Esophageal Diseases; Esophageal Disorder; diseases of esophagus; esophagus disorder; Esophageal Varix; esophageal varices; Esophagitis; Peptic Esophagitis; Reflux Esophagitis; Esophagogastric Junction; Gastroesophageal Junction; esophagogastric sphincter; Esophagus; Food; Food or Food Product; gastric fundus; stomach fundus; Gastroesophageal reflux disease; Acid Reflux; Esophageal Reflux; GERD; Gastro-oesophageal Reflux; Gastroesophageal Reflux; Hand; Light; Photoradiation; Lighting; Illumination; Marketing; Client satisfaction; Patient Satisfaction; Patients; Physicians; Research; Research Personnel; Investigators; Researchers; Risk; Rotation; Safety; Sales; Sensitivity and Specificity; Stomach; gastric; Testing; Traction; United States Food and Drug Administration; Food and Drug Administration; USFDA; Work; Custom; Organ; sensor; improved; Procedures; Chronic; Clinical; Phase; Evaluation; Reflux; Visual; Gastroenterologist; tool; chronic hepatic disease; chronic hepatic disorder; chronic liver disorder; chronic liver disease; sedation; Sedation procedure; Protocol; Protocols documentation; System; gastrointestinal; Esophageal Cancer; Esophagus Cancer; Malignant Esophageal Neoplasm; Malignant Esophageal Tumor; Malignant Tumor of the Esophagus; oesophageal cancer; Malignant neoplasm of esophagus; meetings; Devices; Manpower; personnel; Human Resources; Position; Positioning Attribute; Epidermoid Cell Cancer; Malignant Epidermoid Cell Neoplasm; Malignant Epidermoid Cell Tumor; Malignant Squamous Cell Tumor; Squamous Cell Cancers; Malignant Squamous Cell Neoplasm; preventing; prevent; Diameter; Caliber; Address; Symptoms; Detection; Imaging Instrument; Imaging Tool; Imaging Device; Predictive Value; Resolution; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Validation; Wireless Technology; wireless; Preparation; Development; developmental; point of care; Image; imaging; cost; design; designing; cost effective; safety testing; screening; health care disparity; disparate health care; disparate healthcare; disparity in care; disparity in healthcare; healthcare disparity; chromoscopy; chromoendoscopy; high resolution imaging; imaging capabilities
