Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device

What this Trial Is About

Researchers are evaluating the performance of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) device by analyzing recorded videos from colonoscopy and gastroscopy procedures. The study aims to objectively measure the sensitivity, specificity, and other statistical parameters of the device's results when applied to these videos. Additionally, some of the collected data may contribute to developing future versions of the ME-APDS device. During the study, participants undergo regular colonoscopy and/or gastroscopy tests as part of standard care at a gastroenterology center. An external recording system is connected to the endoscopy device to capture video from the beginning to the end of each procedure. The recording is started and stopped by the physician or assistant during the test, and videos are backed up weekly for analysis. Pathology and procedure reports, with no personal identification details, are sent to the study sponsor along with the videos. Participants will be involved in their usual colonoscopy or gastroscopy procedures, with video recordings taken for offline evaluation of the ME-APDS device's performance. Researchers will assess the quality and completeness of the videos, ensuring they cover at least 80% of the test duration. The primary outcomes include achieving clear video images and acceptable test performance based on medical center standards. The study involves no additional interventions beyond routine care and video recording.

Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).