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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04101318
Eligibility Criteria:
Inclusion Criteria:
1. Has given informed consent to participate by signing the informed consent signature form.
2. Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
3. Currently using a flat product
4. Be at least 18 years of age and have full legal capacity
5. Have had their stoma for at least three months (90 days)
6. Can use a product with a max cut size of 40 mm
7. Has experienced leakage\* under the baseplate at least three times within the last 14 days. \*leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage)
8. Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below
1. Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days
2. Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days
3. Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area
9. Is able to handle the electronic diary (questionnaire/ photo) themselves.
10. Is able to handle (apply, remove, cut etc.) the product themselves
11. Is willing to not use barrier film or barrier cream during the investigation
12. Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation.
13. Is willing to change the product (1pc) or baseplate (2pc) at least every fourth days.
Exclusion Criteria:
1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
\- low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
2. Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.
* Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed.
* Other systemic steroid treatment (e.g. injection, or tablet) are not allowed.
3. Is breastfeeding
4. Is pregnant (based on pregnancy test -urine)
5. Has known hypersensitivity towards any of the products used in the investigation
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04101318
Study Brief:
Protocol Section:
NCT04101318