Evaluation of a New Supporting Ostomy Product

Study Overview
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Brief Summary
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The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.

Official Title
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Evaluation of a New Supporting Ostomy Product

Conditions
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Stoma Ileostomy

Intervention / Treatment
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* Device: CP308


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had a stoma for more than three months Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator) Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm) Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7) Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave) Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods Have self-reported problems with leakage* (three times within 14 days) *Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participat-ed in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP308) protocol Known sensitivity towards test product Known sensitivity towards acrylate Users with a pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Device: CP308<br>* 3 weeks of baseline followed by 2x3 weeks use of the test device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wear time | To evaluate the subject change pattern (wear time) when using the supporting product in 'real-life' situations' | 9 weeks |