An Operable, Portable, and Disposable Ultrathin Endoscope for Evaluation of the Upper Gastrointestinal Tract

Background and Aims: A prototype of a disposable endoscope (DE) with easy viewing of the esophagus has been developed. The aim of this study was to develop a new version of DE with improved functionality and to assess the feasibility of DE as a screening tool for upper gastrointestinal diseases compared with conventional endoscopes. Methods: Diagnostic accuracy and maneuverability of DE were evaluated by comparing endoscopy using DE with conventional endoscopy. Different examiners performed DE endoscopy and conventional endoscopy in a randomized order, blinded to the results. Examiners were asked to respond to a questionnaire about ease of handling and observation using DE in preformed result sheets. Tolerability of DE was also evaluated. Non-sedated participants were asked to respond to a questionnaire about the convenience and satisfaction with DE endoscopy on a nine-point Likert scale. Results: The overall ease of insertion and handling of DE was excellent. The new device enabled observation and evaluation of the entire esophagus with a good agreement between DE endoscopy and conventional endoscopy in terms of endoscopic diagnosis (Kappa value; hiatal hernia; 0.910, reflux esophagitis; 0.949, Barrett’s esophagus, 1.000). Participants suggested that they were more comfortable with DE endoscopy than with conventional endoscopy with a lower symptom score (p = 0.030). Conclusion: The new DE enabled easy observation of the entire esophagus owing to its improved maneuverability, and its diagnostic ability of esophageal diseases was comparable to that of conventional endoscopes. Non-sedated esophagoscopy with this disposable device potentially has widespread applications in outpatient clinics and areas without endoscopic facilities.