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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT07246460
Eligibility Criteria:
Inclusion Criteria:
Male or female, 18 to 80 years old
BWT on IUS \> 3.0mm in the ileum and colonic disease permitted.
Patients naïve to guselkumab.
Stricture phenotype - BWT \> 3 mm, luminal apposition \< 1cm or \< 50% of adjacent normal bowel diameter, and prestenotic dilation of distal ileum. Naïve or anastomotic strictures permitted.
Non-stricture phenotype- ileal CD with no evidence of stricture on IUS, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), ever or fistulizing phenotype.
Exclusion Criteria:
Pregnancy
Ileostomy or colostomy
Significant obesity (BMI \> 35)
Contraindications to initiating GUS such as active infection.
Active malignancy within five years.
Conditions with fibrosis involving other organs such as lungs, kidneys, brain, or skin.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT07246460
Study Brief:
Protocol Section:
NCT07246460