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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02223104
Eligibility Criteria:
Inclusion Criteria:
* patient is at least 18 years old
* patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches
* patient having a colostomy for at least 1 month
* patient using currently a one-piece flat ostomy appliance with closed or drainable bags
* patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches
* patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days
* patient covered by social security
Exclusion Criteria:
* patient receiving or having received, within the last month, chemotherapy or radiotherapy
* patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin
* patient already participating in another clinical study or who have previously participated in this investigation
* pregnant or breast-feeding woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02223104
Study Brief:
Protocol Section:
NCT02223104