To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
12
Independent Nurse Consultant LLC
Tucson, Arizona, United States
Safety
To assess the condition of the peristomal skin and stoma and number and frequency of adverse events
Time frame: Study duration will be 10 days
Performance/Efficacy
To assess ease of use including ease of application and removal, comfort and security along with wear time
Time frame: The study will be for 10 days
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