An animal experimental study of a new portable endoscopic system for upper gastrointestinal endoscopy / 中华消化内镜杂志

ABSTRACT

Objective:To evaluate the operating performance, effectiveness and safety of a new portable endoscopic system for upper gastrointestinal endoscopy in an animal model.Methods:A parallel control, non-inferiority study was designed. Ten healthy Bana pigs were selected as the study subjects, and underwent upper gastrointestinal endoscopy using portable endoscope followed by Olympus GIF-Q260 endoscope. The instrument quality, image quality and safety of the new system were evaluated by means of quantitative scores.Results:The time for deployment and installing of the new portable endoscopic system during single operation was 110.24±8.93 s and 91.33±11.59 s, respectively, and the time for the endoscope with disposable protective cover was 233.48±17.06 s. The time of attracting 400 mL normal saline of the portable endoscope and Olympus endoscope was 56.44±5.18 s and 33.71±3.56 s, respectively. The water vapor attraction performance of the portable endoscope was not as good as the Olympus endoscope, but still met the technical requirements of medical devices (attraction capacity >400 mL/min). While in terms of the seal property, biopsy channel, softness and curvature of gastroscopy body, knob operation, and field of view, the two endoscopic systems were equivalent. In terms of image quality evaluation, including clarity, distortion, color resolution, illumination and quality comprehensive evaluation, the performance of the new portable endoscopic system was similar to that of the Olympus endoscopic system. One pig developed nausea during operation with the Olympus endoscope. No adverse events occurred during operation with the new portable endoscope.Conclusion:The new portable endoscopic system is easy to assemble. In terms of device quality, image quality and safety, the new portable endoscopic system is similar to the clinically used Olympus endoscopic system. Therefore, the new portable endoscope system is safe and effective for upper gastrointestinal endoscopy.