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Collecting Recorded Videos of Colonoscopy

Collecting Recorded Videos of Colonoscopy

Recruiting
18 years and older
All
Phase N/A

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Overview

The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.

Description

Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.

Secondary objectives

• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.

Eligibility

Inclusion Criteria:

        Subjects must meet all the - criteria related to regular colonoscopy according to the
        standard of care at the Gastroenterology Department of the selected center, _In addition
        the following - criteria have to be met to be eligible for the study:
          1. Able to read, understand and provide written Informed Consent;
          2. Females or males - older than 18 years old
        Exclusion Criteria:
        Any of the following colonoscopy related exclusion criteria will exclude the subject from
        the study:
          -  Bleeding disorder or unacceptable risk of bleeding
          -  Terminal illness or life threatening malignancy

Study details
    Colon Polyp

NCT03891251

Magentiq Eye LTD

14 October 2025

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