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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01243294
Eligibility Criteria:
Inclusion Criteria:
* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Be able to handle the bags themselves (application, removal)
* Have a colostomy with a diameter less than 45 mm
* Have had a colostomy for at least 3 months
* Currently use a 1-piece flat ostomy appliance with closed bag
* is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
* Use minimum 1 product per day
* Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
* Have the mental capacity to understand the study and questionnaires
Exclusion Criteria:
* Use irrigation during the study (flush the stoma with water).
* Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
* Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
* Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
* Are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01243294
Study Brief:
Protocol Section:
NCT01243294