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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05390151
Eligibility Criteria:
Inclusion Criteria:
* Patients with fistula involving more than one-third of the external anal sphincter
* Single, continuous fistula tract at time of inclusion
* Loose seton present in fistula tract for 2 months or more at time of inclusion
* Age ≥ 18
* Able to complete an informed written consent, understand its implications and contents, and participate in follow-up
Exclusion Criteria:
* Fistula tract \< 1 cm
* Complex fistula tract system (branching of fistula tract inside the sphincter complex)
* Pregnancy
* HIV-positive
* Crohn´s disease, Ulcerative colitis
* Fistula due to malignancy
* Tuberculosis
* Hidradenitis Suppurativa
* No internal opening
* Unable to undergo or contraindications to MRI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05390151
Study Brief:
Protocol Section:
NCT05390151