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 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 4:28 PM
NCT ID:
NCT05903066
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age
* Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.
* Indication for MRE based on routine clinical practice validated by the treating physician
* Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).
* The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.
* A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.
Exclusion Criteria:
* Pregnancy during the study
* People unable to give consent (because of their physical or mental state)
* Absence of written consent
* Ulcerative colitis or unclassified IBD
* Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.
* Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)
* Severe obstructive symptoms
* Symptomatic intra-abdominal abscess
* Contraindication for MRI
* Isolated perianal disease without luminal location
* MRE images of poor quality, based on previously defined criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05903066
Study Brief:
Protocol Section:
NCT05903066