A Prospective Investigation on the Safety and Feasibility of the investigative endoscopic system in the visualization of the upper digestive tract and facilitation of tool delivery for diagnostic or therapeutic interventions.

The purpose of this research study is to assess the safety and feasibility of a new device designed for the visualization of the upper digestive tract and facilitation of tool delivery for diagnostic or therapeutic interventions. Subjects will undergo a procedure with a device which is a software- controlled, electro-mechanical system designed to assist qualified physicians to navigate a GI endoscope and endoscopic tools in the upper GI tract using endoscopic visualization for observation, diagnostic procedures, and/or endoscopic treatment. The device is similar to a conventional endoscopy; the investigational device will be inserted through the mouth and navigated into the upper GI tract. Procedures will occur in an endoscopy theatre and will be performed by qualified physicians. Procedures may be performed under general anesthesia or moderate sedation. Patients will be informed of the anesthesia method prior to the procedure. The study procedure will last for approximately 60 minutes. Patients will be monitored in the hospital post-procedure and prior to discharge and will complete one follow-up visit via clinic visit or telehealth within 30 days of the procedure. Follow up is in accordance with the follow-up practice for this procedure without an investigational device and will involve the study doctor asking the patient whether they experienced any adverse events including any hospitalizations. Patients can also self-monitor themselves and in the event of a suspected complication, they can contact the study team. Strategies used to assess adherence to the intervention include photo documentation of the access to landmarks in the upper GI tract in the same manner as standard EGD or other endoscopy procedures.