A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
Completed · Not applicable
Conditions studied: Screening Colonoscopy, Surveillance Colonoscopy
In brief
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.
Key facts
- Study ID
- NCT04640792
- Run by
- Magentiq Eye LTD
- People needed
- 952
- Starts
- 2020-10-01
- Expected to finish
- 2022-02-10
- Last updated by the study team
- 2022-05-05
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score (BBPS) <6 or any segment <2 (each procedure report will include the BBPS);
- Any woman who is pregnant or potentially pregnant.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Columbia University Irving Medical Center — New York, New York, United States
- MetroHealth System — Cleveland, Ohio, United States
- Erlanger Health System — Chattanooga, Tennessee, United States
- GastroZentrum Lippe — Bad Salzuflen, Germany
- Mainz University Medical Center — Mainz, Germany
- Assuta — Haifa, Select State, Israel
- Department of Gastroenterology, Shamir Medical Center, Israel — Be’er Ya‘aqov, Israel
- Shamir Medical Center — Be’er Ya‘aqov, Israel
- Hadassah Medical Organization — Jerusalem, Israel
- The Radboud University Medical Center — Nijmegen, Netherlands
Full record on ClinicalTrials.gov
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