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To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
Full description
This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.
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Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria - The following subjects must not be included into the study:
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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