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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT01272869
Eligibility Criteria:
Inclusion Criteria:
* Be at least 18 years of age and have full legal capacity.
* Have given written informed consent.
* Be able to fill in the Case Report Form.
* Be ileostomy operated and have had a stoma for at least 6 months.
* Experience ballooning at least once per week.
* Be able to manage the bags themselves (application, removal).
* Be able to use a flat base plate.
* Have a stoma with a diameter less than 60 mm
Exclusion Criteria:
* Persons who irrigate
* Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* Pregnant or breastfeeding.
* Participate in other test at the same time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01272869
Study Brief:
Protocol Section:
NCT01272869