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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT01612195
Eligibility Criteria:
Inclusion Criteria:
Complex anal fistula as defined by
* high transsphincteric fistula
* extrasphincteric fistula
* suprasphincteric fistula
* recurrent fistula
* multiple fistula openings, including horseshoe fistula
* imperfect continence- jeopardized anal continence (anterior transsphincteric fistula, prior anal surgery)
Exclusion Criteria:
* Uncomplicated fistula curable by simple fistulotomy
* History of inflammatory bowel disease
* Chronic immunosuppressive treatment (ie, systemic steroids for \>3 days)
* Clinical heart failure as defined by a CCS angina severity class ≥ III
* Untreated cancer or cancer diagnosed/treated (all modalities) within 6 months
* Estimated life expectancy inferior to 6 months
* Incompetent subject
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01612195
Study Brief:
Protocol Section:
NCT01612195