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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01314092
Eligibility Criteria:
Inclusion Criteria:
* a patient who has complex perianal fistula
* a patient who is negative in pregnancy test
* a patient who has submitted a written consent
Exclusion Criteria:
* a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
* a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
* a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
* a patient who has an autoimmune disease
* a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* a patient who has sepsis or active tuberculosis
* a patient who is pregnant or breast feeding
* a patient who has inflammatory Bowel disease
* over 2cm in diameter of fistula
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01314092
Study Brief:
Protocol Section:
NCT01314092