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

NCT ID: NCT06566872

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Colon Polyp

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

ME-APDS

No Intervention

Intervention Type: DEVICE

Other Intervention Names

Automatic Polyp Detection System (ME-APDS) Medical Device

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magentiq Eye LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haim Shirin, Prof.

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Department of Shamir Medical Center, Israel

Locations

Department of Gastroenterology, Shamir Medical Center, Israel

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Dror Zur, Ph.D.

Role: CONTACT

dror@magentiq.com

+972(54)7555922

Facility Contacts

Haim Shirin, Prof

Role: primary

+972(0)89779655

Other Identifiers

CL-0041

Identifier Type: -

Identifier Source: org_study_id