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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT02610569
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient between 18 and 70 years old
* Patient with UC requiring treatment with anti-TNFalpha or vedolizumab
* Patient affiliated to a social security scheme
* Patient able to understand and follow the study instructions
* Patient having signed an informed consent form
Exclusion Criteria:
* Patient with severe and acute colitis
* Patient with Crohn's disease or non-classified colitis
* Patient with an indication for surgical management of UC
* Patient with a history of sub-total or total colectomy, or with colostomy or ileostomy.
* Patient with a history of intestinal irradiation
* Patient with a known or suspected intestinal stricture
* Patient with clinical signs suggestive of intestinal stricture
* Patient with dysphagia with choking on solid food or swallowing disorders
* Patient with a contra-indication for an anti TNFalpha treatment
* Patient with a contra-indication for conventional endoscopy (colonoscopy or recto-sigmoidoscopy)
* Patient with congestive heart failure or severe renal impairment
* Patient with a pacemaker or other implanted electronic medical device
* Patient participating in another interventional clinical trial
* Pregnant or nursing woman
* Vulnerable individuals: persons deprived of liberty, under tutelage or guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02610569
Study Brief:
Protocol Section:
NCT02610569