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

Not Applicable

Completed

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

Detailed Description: It will be a 1:1 randomization into the two possible treatment sequences

Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days).

All visits will be performed as remote virtual calls. At the visits, the investigator will give instructions for the coming period and check that the trial is running as planned. At every bag change the subject will be asked to complete a questionnaire.

A follow-up call will be scheduled 7±1 days after each test visit to ensure compliance with the provided product and study procedures. Additional calls may be scheduled if needed.

Minimum 40 participants will be enrolled and randomized.

Recruitment & Eligibility

Inclusion Criteria

Has given written consent to participate by signing the Informed Consent Signature Form
Be at least 18 years of age and have full legal capacity
Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves
Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale)
Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size
Have had their ostomy for at least 90 days
Be willing to change the bag at least twice per week
Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation
Is willing to use 2p maxi open bags during the investigation

Exclusion 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 spray
- Low 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-feeding
Have a loop ileostomy
Is currently using convex baseplate
Has known hypersensitivity towards any of the products used in the investigation

Arm && Interventions

Group	Intervention	Description
New Coupling	Iris - new coupling	-
Comparator Device	Sensura Mio Click	-

Primary Outcome Measures

Name	Time	Method
Leakage Through Coupling Registered at Each Bag Change (Yes/no)	3 weeks	Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.

Secondary Outcome Measures

Name	Time	Method
How Satisfied Are You With the New Coupling?	3 weeks - evaluated at the end of the study	Satisfaction with new coupling evaluated at end of study by a question on a 4-point scale (very satisfied - satisfied - dissatisfied - very dissatisfied)
Would You Consider Using the New Coupling in the Future?	Based on 3 weeks - evaluated at the end of the study period	Preference evaluated at end of the investigation by the question "Would you consider using the new coupling in the future?" (Yes/No)