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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT00830661
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects 18 years of age or older.
* Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
* Has a documented diagnosis, confirmed by physical exam and/or endorectal ultrasound (if available), of a trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).
Exclusion Criteria:
* History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).
* History of connective tissue disease.
* Rectovaginal fistula.
* Presence of horseshoe fistula.
* History of immunosuppression therapy/treatment within previous six months.
* Presents of a proximal diversion and refractory fistula.
* Any physical conditions, disease, or disorder that would exclude subject from being a candidate for elective surgery.
* Known history of allergy to pork or pork products.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00830661
Study Brief:
Protocol Section:
NCT00830661