NL-OMON50965CompletedNot Applicable
Randomized Two Arm Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Magentiq Eye's Automatic Polyp Detection System (ME-APDS) During Colonoscopy - Magentiq Eye Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Magentiq Eye LTD
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Able to provide written informed consent prior to any study procedures;
- •2. Able to communicate clearly with the Investigators and study staff;
- •3. Males and females aged between 18 * 90 years of age;
- •4. Referred and Scheduled for either screening or surveillance colonoscopy
- •which is sched-uled every 3 to 10 years;
- •5. Has not been referred to the test after positive iFOBT.
Exclusion Criteria
- •1. Has a known or suspected colorectal tumor or polyp on referral;
- •2. Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection,
- •intervention to stop a lower gastro-intestinal bleeding, etc.);
- •3. Has not corrected anticoagulation disorders;
- •4. Inability to provide informed consent;
- •5. Has any clinically significant condition that would, in the opinion of the
- •investigator, pre-clude study participation;
- •6. Unable or unwilling, in the opinion of the Investigator to comply with the
- •requirements of the protocol;
- •7. Employees of the investigator and study site or the sponsor, as well as
- •family members of the employees or the investigator or the sponsor;
- •8. Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score
- •(BBPS) <6 or any segment <2 (each procedure report will include the BBPS);
- •9. Any woman who is pregnant or potentially pregnant.
Investigators
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