A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/3/2018 |
Start Date: | September 2015 |
End Date: | March 2016 |
The aim of the study is to obtain an understanding of relevant parameters affecting the
performance of ostomy products.
performance of ostomy products.
Inclusion Criteria:
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have an ileostomy or colostomy
- Have had their ostomy for at least 3 months
- Must use 1 piece open or closed ostomy products during the test period
- Currently using a 1 piece. flat product
- Must be able to use custom cut product
- Have intact peristomal skin
- Has experienced leakage (seeping) under the baseplate at least three times during the
last two weeks
- Are evaluated to be suitable for a soft convex product
Exclusion Criteria:
- Currently receiving or have within the past 2 month received radio- and/or
chemotherapy
- Currently or having within the past month received topical steroid treatment in the
peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously
participated in this investigation
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