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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT03904212
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Crohn´s Disease
* Perianal fistula with out branching or cavities with one external and one internal opening, which due to the risk for development of incontinence is not suitable for lay-open procedure, meaning: 1) all anterior interspinchteric and low transpinchteric (involving\<1/3 of spinchter) in women 2) high interspinchteric fistulas 3) high transspinchteric (\>1/3 of sphincter), suprasphincteric and ekstrasphincteric fistulas 4) intersphincteric or low transsphincteric fistula in patients with fecal incontinence and/or fecal urge.
* no or minimal luminal disease activity by colonoscopy \< 3 months before treatment defined by Simple Endoscopic Severity for Crohn´s Disease\<3
* Prior optimal medical treatment for fistulas (immunmodulators, antibiotics and/or anti-TNF-alfa treatment) with out achieving fistula healing
* Treatment with seton for a minimum of 6 weeks
* Speaks and understand Danish
Exclusion Criteria:
* Pregnancy
* Changes in immunmodulator or anti-TNFalfa treatment \< 12 weeks
* Anovaginal fistulas
* Rectal or anal stenosis
* Active proctitis
* Stoma
* Previous surgery for fistulas besides simpel drainage or seton
* Smoker
* Insulin-dependent diabetes, conditions inducing defective immunity, pelvic radiation
* pelvic MRI contraindicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03904212
Study Brief:
Protocol Section:
NCT03904212