Evaluation of Single-Use Versus Reusable Gastroscopes for Elective and Subacute Upper Gastrointestinal Procedures in an Endoscopy Unit

What this Trial Is About

This clinical trial investigates how single-use gastroscopes compare to reusable gastroscopes in patients undergoing elective or subacute upper gastrointestinal procedures in an endoscopy unit. The study aims to assess endoscopists evaluations of performance, as well as the economic impact of using single-use gastroscopes during times when the capacity to reprocess reusable gastroscopes is reduced. Researchers are also examining technical success, procedural complications, and key clinical findings between the two types of gastroscopes. Participants will undergo gastroscopy in two separate study periods. In the first period, all gastroscopies performed between 1100 and 1500 will use single-use Ambu aScope Gastro devices. In the second period, gastroscopies during the same time frame will be conducted with reusable Olympus diagnostic gastroscopes. This parallel design compares clinical performance and costs associated with each gastroscope type. During the study, participants will be monitored for technical success of the procedure, any complications within 24 and 72 hours, and mortality at 30 days. Researchers will collect data on procedure duration, frequency of endoscopic findings, biopsy adequacy, and crossover rates between devices. Endoscopists will rate usability immediately after procedures, and cost per gastroscopy will be evaluated on the procedure day. The overall participation spans from gastroscopy through follow-up assessments related to safety and diagnostic outcomes.

Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit