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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT00653094
Eligibility Criteria:
Inclusion Criteria:
* Male and Female age greater than 18
* Patients suffering from Crohn's disease
* Patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (Seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug
* Able and willing to sign an informed consent
* Patient will be available for follow up.
Exclusion Criteria:
* Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial
* Known immunodeficiency.
* Exclusion Criteria for injecting biologic adhesive:
* Known allergy to fibrin glue or one of its components.
* An undrained perianal abscess, diagnosed by a physical examination or imaging methods.
* Known Alcohol or drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00653094
Study Brief:
Protocol Section:
NCT00653094