A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy (NCT04640792) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
United States, Germany952 participantsStarted 2020-10-01
Plain-language summary
ME-APDS is a device (software-based with hardware) developed by Magentiq Eye LTD and intended to support the decision of the endoscopist on polyps which appear in the colonoscopy video during the colonoscopy procedure.
This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq Eye Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC) in patients referred for either screening or surveillance colonoscopies.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to provide written informed consent prior to any study procedures;
✓. Able to communicate clearly with the Investigators and study staff;
✓. Males and females aged between 18 - 90 years of age;
✓. Referred and scheduled for either screening colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
✓. Has not been referred to the test after positive iFOBT.
Exclusion criteria
✕. Has a known or suspected colorectal tumor or polyp on referral;
✕. Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.);
✕. Has not corrected anticoagulation disorders;
✕. Inability to provide informed consent;
✕. Has any clinically significant condition that would, in the opinion of the investigator, preclude study participation;
✕. Unable or unwilling, in the opinion of the Investigator to comply with the requirements of the protocol;
✕. Employees of the investigator and study site or the sponsor, as well as family members of the employees or the investigator or the sponsor;
What they're measuring
1
Comparison of the Adenoma Per Colonoscopy (APC) between the two arms
Timeframe: During the Colonoscopy Procedure
2
Comparison of the Adenoma Per Extraction (APE) between the two arms
. Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score (BBPS) \<6 or any segment \<2 (each procedure report will include the BBPS);