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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01995357
Eligibility Criteria:
Inclusion Criteria:
1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy/colostomy for at least 3 months
4. Have a stoma with a diameter between 15 and 36 mm
5. Be able to handle the products themselves
6. Be able to use a custom cut product
7. Normally experience faeces under the base plate at least 3 times during 2 weeks
8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
9. Be willing to test the test products without using paste and/or ring
10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
11. Be suitable for participation in the investigation
12. Be able to present a negative result of a pregnancy test - for women of childbearing age
Exclusion Criteria:
1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Use irrigation during the investigation (flush the intestines with water)
6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
7. Have a loop stoma
8. Have known hypersensitivity towards any of the test products (including adhesive remover)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01995357
Study Brief:
Protocol Section:
NCT01995357