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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT06505304
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 years and 75 years.
* Established diagnosis of CD at least six months prior to study.
* Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.
Exclusion Criteria:
* Inability to provide consent.
* Presence of serious co-morbidities (clinical contraindication).
* Presence of ostomy.
* Pregnancy or breastfeeding.
* Contraindication for colonoscopy or biopsies.
* Boston Bowel Preparation Scale Score \<2 in the rectum plus left-sided colon.
Exclusion criteria for pCLE only:
* Allergy to nuts or shellfish.
* Severe or uncontrolled asthma.
* Use of beta blockers.
* Previous history of reaction to fluorescein.
Patients excluded from pCLE can still enter the study and undergo only standard-of-care endoscopy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06505304
Study Brief:
Protocol Section:
NCT06505304