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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT01561066
Eligibility Criteria:
Inclusion Criteria:
* older than 18 years
* presence of one or more fistulas
* fistulas of low-output volume (\< 200ml/24h)
Exclusion Criteria:
* failure to meet inclusion criteria
* mental handicap
* extreme thinness
* fistulous tract length \< 2 cm
* fistulous tract diameter \> 1 cm
* entero-atmospheric fistulas
* Crohn's disease-related fistulas
* any conditions that might impede spontaneous closure of the fistula, such as complex tracts, associated abscesses, residual disease, foreign bodies or distal obstruction
* any conditions that might increase the risk of auto-transfusion, including hypertension, or diabetes; and acquired immune deficiency syndrome (AIDS)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01561066
Study Brief:
Protocol Section:
NCT01561066