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

Launched by MAGENTIQ EYE LTD · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called ME-APDS, which is used during colonoscopy and gastroscopy tests. These tests help doctors check for issues in the colon, stomach, and esophagus, including conditions like colon polyps. The main goal is to see how well this device works by capturing clear videos during the tests. Researchers will also evaluate if the device meets the medical center’s quality standards and if it can be improved for future use.

To be eligible for the study, participants must be over 18 years old, able to read and understand the information provided, and scheduled for a regular colonoscopy or gastroscopy. However, those with bleeding disorders or serious, life-threatening illnesses cannot join. If you participate, you can expect that at least 80% of the video from your test will be recorded, helping researchers learn more about the device’s performance. This trial is currently recruiting participants, and it’s an important step toward improving how these tests are done in the future.

Gender

ALL

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:
• 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