The study shall mainly help to better evaluate the performance the ME-APDS device and secondly it may help the development of additional future versions of the ME-APDS. Primary endpoints * Clear video of the colon or the stomach or the esophagus achieved during the test. * Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial. Secondary endpoints • A recorded video of at least 80% of the actual test duration.
Primary objectives • To support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters of its results achieved from running it on the collected recorded videos of Colonoscopy and Gastroscopy tests of the general population. Secondary objectives • Some of the data might be used also for the development of future versions of the ME-APDS Each subject will pass regular colonoscopy and/or gastroscopy test during which an external recording system connected to the secondary "video out" connector of the endoscopy processing device will record the video presented on the endoscopy device screen from the beginning of the test till its end. The standard off-the shelf recording device will be connected to the endoscopy device's connector by the testing physician or his/her assistant during the test's preparation phase. At the beginning of the test the testing physician or his/her assistant will press on recording start button, and at end of the test, the testing physician or his/her assistant will press on recording stop button. At the end of each week, the recorded video will be backed-up from the recording device to an external storage with two copies, one for record keeping of the main investigator, and one for the sponsoring entity. Pathology and procedure reports without any identification details will sent to the sponsor with the recorded video.
Study Type
OBSERVATIONAL
Enrollment
700
No Intervention
Department of Gastroenterology, Shamir Medical Center, Israel
Be’er Ya‘aqov, Israel
RECRUITINGTo support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters.
Clear video of the colon or the stomach or the esophagus achieved during the test.
Time frame: during colonoscopy and gastroscopy procedure
Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.
Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.
Time frame: during colonoscopy and gastroscopy procedure
A recorded video of at least 80% of the actual test duration.
A recorded video of at least 80% of the actual test duration.
Time frame: during colonoscopy and gastroscopy procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.