An Operable, Portable, and Disposable Ultrathin Endoscope for Evaluation of the Upper Gastrointestinal Tract
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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.
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.
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).
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.
KeywordsEndoscopy Disposable endoscope Esophagus Screening
Food and drug administration
Hospital anxiety and depression
Positive predictive value
Negative predictive value
Percutaneous endoscopic gastrostomy
Gastroesophageal reflux disease
IntroMedic Co., Ltd provided novel disposable endoscopy. This research was supported by the Medical Device Development Center under the direction of the Korea Evaluation Institute of Industrial Technology (Grant No. 10049769) and the program of Global Research and Development Center through the National Research Foundation of Korea, funded by the Ministry of Science, ICT and Future Planning (Grant No. NRF-2011-00316441).
Compliance with ethical standards
Conflict of interest
All authors declare that they have no conflict of interest to disclose.
This study was approved by the Institutional Research Ethics Board of Seoul St Mary’s Hospital (KC15DNSI0929) and conformed to the Declaration of Helsinki.