Colorectal adenomas and polyps
Conditions
Interventions
Colonoscopy
Sponsors
Magentiq Eye LTD
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints • Incidence of Serious AEs (SAEs) Efficacy Endpoints Co-Primary • Adenoma Per Colonoscopy (APC): between the Magentiq Eye-assisted colonoscopy and conventional colonoscopy, calculated only on the first examination. • Adenoma Per Extraction (APE): between the Magentiq Eye-assisted colonoscopy and conventional colonoscopy, calculated only on the first examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The Adenoma Miss Rate (AMR), calculated as the number of ade-nomas detected in the second examination divided by the total number of adenomas detected in the both examinations, between Magentiq Eye-assisted colonoscopy as first examination (AMR of MAEC) and conventional colonoscopy as first examination (AMR of CC). • Adenoma Detection Rate (ADR), calculated as the number of pa-tients who have one or more adenomas detected and removed di-vided by the total number of patients, between the Magentiq Eye-assisted colonoscopy and conventional colonoscopy, calculated only on the first examination. | — |
Countries
Netherlands
Outcome results
None listed