Comparing Single-use and Reusable Gastroscopes for Gastroscopy Procedures in the Operating Room in Adults with Upper Gastrointestinal Disorders

What this Trial Is About

Researchers are evaluating whether single-use gastroscopes perform as well as reusable gastroscopes during gastroscopy procedures conducted in the operating theater. The study aims to determine if the technical success and performance characteristics of single-use devices match those of reusable ones across patients who need gastroscopy in this setting. Participants will first undergo gastroscopy using single-use gastroscopes, specifically the CE-marked Ambu aScope Gastro and Ambu aScope Gastro Large devices. In a subsequent period, gastroscopies will be performed using reusable gastroscopes from Olympus, including both diagnostic and therapeutic models. This comparison spans acute, subacute, and elective patients undergoing procedures in the operating room. Throughout the study, researchers will assess technical success from admission until discharge, with follow-up up to three months. They will also monitor complications at 24 and 72 hours post-procedure, mortality at 30 days, procedure duration, endoscopist satisfaction, and the need for additional gastroscopies or readmission. Biopsy targeting success and time from procedure to discharge will also be evaluated to understand the overall performance and outcomes associated with each gastroscope type.

Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR