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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT02362360
Eligibility Criteria:
Inclusion Criteria:
* Have given written informed consent and in DK: signed a letter of authority
* Be at least 18 years of age and have full legal capacity
* Have had their ileostomy or colostomy for at least 3 months
* Able to use a baseplate size 15 to 40 mm
* Be able to handle the product themselves
* Normally experience faeces under the baseplate at least 3 times during 2 weeks
* Currently using a 2-piece flat product with mechanical coupling
* Willing to test both the Coloplast test product and the comparator product
* Willing to use an open bag size maxi during the investigation
* Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
* Willing to use at least 1 baseplate every 3rd day during the investigation
* Is able to use a custom cut product
* Be suitable for participating in the investigation
Exclusion Criteria:
* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
* Are pregnant or breastfeeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestines with water)
* Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
* Have a loop ostomy
* Have known hypersensitivity towards any of the products used in the investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02362360
Study Brief:
Protocol Section:
NCT02362360