Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).
Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device
Magentiq Eye LTD
700 participants
May 16, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Subjects must meet all the - criteria related to regular colonoscopy and/or gastroscopy according to the standard of care at the Gastroenterolgy Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:
- Able to read, understand and provide written Informed Consent;
- Females or males - older than 18 years old
Exclusion Criteria2
- Bleeding disorder or unacceptable risk of bleeding
- Terminal illness or life threatening malignancy
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Interventions
No Intervention
Locations(1)
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NCT06566872