Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Inclusion criteria

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Be able to handle the products themselves
• Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
• Have had their ileostomy for at least 3 months
• Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
• Currently using midi or maxi bags
• Willing to use minimum 1 product every second day (max. 2 days wear time)
• Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
• Must be able to cut products themselves

Exclusion criteria

• Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
• Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Known hypersensitivity of the product components and/or ingredients