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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT02156557
Eligibility Criteria:
Inclusion Criteria:
* Subjects felt to be at increased risk for CRC and colonic polyps
OR
-Subjects with known colonic adenomas scheduled for colonic resection
OR
* Subjects who are scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.
* Subjects who are scheduled for outpatient colonoscopy in the medical procedures unit at the University of Michigan Health Center
* All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) who meet the inclusion/exclusion criteria will be included. Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study
* Adults aged 18 to 100 years
* Willing and able to sign informed consent
* The effects of Colon KCC Heptapeptide (5-FITC-labeled peptide) on the developing human fetus are unknown. For this reason, women of childbearing potential must have a negative pregnancy test on the day of the procedure prior to receiving the Colon KCC Heptapeptide (5-FITC-labeled peptide agent) or be post-menopausal. Post-menopausal women are defined as post-hysterectomy, or over 40 and at least 18 months without menses and not on birth-control.
Exclusion Criteria:
* Subjects with known allergy or negative reaction to fluorescein or derivatives.
* Subjects on active chemotherapy or radiation treatment
* Pregnant or trying to conceive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02156557
Study Brief:
Protocol Section:
NCT02156557