Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT04640792
Eligibility 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 colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
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, preclude 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04640792
Study Brief:
Protocol Section:
NCT04640792