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

  • Donghoon Kang
  • Chul-Hyun LimEmail author
  • Myung-Gyu ChoiEmail author
  • Hanhee Lee
  • Jin Su Kim
  • Yu Kyung Cho
  • Jae Myung Park
  • Young Seok Cho
  • Bo In Lee
  • In Seok Lee
Original Article
  • 27 Downloads

Abstract

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.

Keywords

Endoscopy Disposable endoscope Esophagus Screening 

Abbreviations

DE

Disposable endoscope

FDA

Food and drug administration

EGJ

Esophagogastric junction

HAD

Hospital anxiety and depression

PPV

Positive predictive value

NPV

Negative predictive value

PEG

Percutaneous endoscopic gastrostomy

SD

Standard deviation

GERD

Gastroesophageal reflux disease

Notes

Acknowledgments

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.

Ethical approval

This study was approved by the Institutional Research Ethics Board of Seoul St Mary’s Hospital (KC15DNSI0929) and conformed to the Declaration of Helsinki.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Catholic Photomedicine Research Institute, Seoul St. Mary’s HospitalThe Catholic University of KoreaSeoulKorea

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