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

Magentiq Eye

Status: Enrolling

Conditions: Colon Polyp

Treatments: Device: ME-APDS

Study type: Observational

Funder types: Industry

Identifiers

NCT06566872

CL-0041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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:

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/gastroscopy related exclusion criteria will exclude the subject from the study:

• Bleeding disorder or unacceptable risk of bleeding
• Terminal illness or life threatening malignancy