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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT01103466
Eligibility Criteria:
Inclusion Criteria:
1. Have given written Informed Consent
2. Are at least 18 years old
3. Had their ileostomy for minimum 3 months with a size between 20-40 mm
4. Have mental capacity to understand study guidelines and questionnaires
5. Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
6. Experience leakage under the base plate at least one a week
7. Are currently using a flat 2-piece base plate with mechanical coupling
8. Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study
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Exclusion Criteria:
1. Pregnant or breast-feeding
2. Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
3. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
4. Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
5. Currently using a convex system
6. Participating in other clinical studies or have previously participated in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01103466
Study Brief:
Protocol Section:
NCT01103466