Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click.

Inclusion Criteria:Has given written consent to participate by signing the Informed Consent Signature FormBe at least 18 years of age and have full legal capacityIs able to handle (apply, remove, cut, etc.) the product and do the assessments themselvesHas an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale*)*See appendix 1Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling sizeHave had their ostomy for at least 90 daysBe willing to change the bag at least twice per weekIs willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigationIs willing to use 2p maxi open bags during the investigationExclusion Criteria:Is currently receiving or have within the past 60 days received radio-and/or chemotherapy- low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or sprayLow dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed.Other systemic steroid treatment (e.g., injection or tablet) are not allowed.Is pregnant and/or breast-feedingHave a loop ileostomyIs currently using convex baseplateHas known hypersensitivity towards any of the products used in the investigation