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NCT Number: NCT06566872

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Shamir Medical Center, Israel

Be’er Ya‘aqov, Israel

Location status: Recruiting

Location contact

Haim Shirin, Prof

CONTACT

+972(0)89779655

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:

  • Able to read, understand and provide written Informed Consent;
  • 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

Treatment and study plan

ME-APDS

Device

No Intervention

Other names: Automatic Polyp Detection System (ME-APDS) Medical Device

Primary outcomes

  1. 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.

    Time frame: during colonoscopy and gastroscopy procedure

    Clear video of the colon or the stomach or the esophagus achieved during the test.

  2. 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

    Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.

Secondary outcomes

  1. A recorded video of at least 80% of the actual test duration.

    Time frame: during colonoscopy and gastroscopy procedure

    A recorded video of at least 80% of the actual test duration.

Study contacts

Contact information is provided by the study sponsor or research team.

Dror Zur, Ph.D.

CONTACT

[email protected]

+972(54)7555922

Sponsors and collaborators

Lead sponsor

Magentiq Eye LTD

Industry

Registry information

Official study title

Collecting Recorded Videos of Colonoscopy Gastroscopy Tests for the Evaluation of the Magentiq Eye Automatic Polyp Detection System (ME-APDS) Medical Device

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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