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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT02117232
Eligibility Criteria:
Inclusion Criteria:
1. The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.
2. Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
3. Age from 17 to 90 years.
4. Be willing and able to comply with the requirements of the protocol.
5. Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
6. Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.
Exclusion Criteria:
1. Subjects with a history of previous colonic resection.
2. Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
3. Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
4. Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
5. Subjects who received any experimental drug or device within the previous three months.
6. Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
7. Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
90 Years
Study:
NCT02117232
Study Brief:
Protocol Section:
NCT02117232