Status:
RECRUITING
Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).
Lead Sponsor:
Magentiq Eye LTD
Conditions:
Colon Polyp
Eligibility:
All Genders
18+ years
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 vid...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06566872
Start Date
May 16 2022
End Date
December 1 2025
Last Update
August 28 2024
Active Locations (1)
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1
Department of Gastroenterology, Shamir Medical Center, Israel
Be’er Ya‘aqov, Israel