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:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT01722058
Eligibility Criteria:
The inclusion criteria for this proposed clinical study are:
* Subjects who are scheduled for outpatient colonoscopy.
* All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, comorbidities) who meet the inclusion/exclusion will be included. Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study
* Adults aged 18 years to 100
* Willing and able to sign informed consent
* Willing and able to get the repeat clinical labs
* The effects of the Colon KCC Heptapeptide (labeled with 5-FITC) on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative pregnancy test on the day of the procedure 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.
The exclusion criteria for this proposed clinical study are:
* Subjects with known allergy or negative reaction to fluorescein or derivatives.
* Subjects on active chemotherapy or radiation treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01722058
Study Brief:
Protocol Section:
NCT01722058