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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT05584228
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 70 years
* Male or female
* Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms
* CREOLE score \> 2
Exclusion Criteria:
* Adults under guardianship, safeguard justice or trusteeship
* Pregnant or breastfeeding female
* Acute bowel obstruction requiring urgent surgical intervention
* Suspected or confirmed gastrointestinal perforation
* Concurrent active perianal sepsis
* Internal fistulizing disease in association with strictures
* Colonic stenosis and/or colonic active disease at screening endoscopy
* Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines
* Use of corticosteroids (prednisolone \> 20 mg daily or equivalent) within 4 weeks prior to visit V0
* Treatment with any biologics within 8 weeks before visit V0
* Presence of a stoma
* HIV/HCV/HBV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05584228
Study Brief:
Protocol Section:
NCT05584228