Collecting Recorded Videos of Colonoscopy Screening Tests

Magentiq Eye

Status: Completed

Conditions: Colon Polyp

Treatments: Other: Collecting recorded videos of Colonoscopy screening tests of the general population

Study type: Observational

Funder types: Industry

Identifiers

NCT03891290

0009-16-HYMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the Gastroenterolgy Department of the selected center. In addation, 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