Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Study Overview
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Brief Summary
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To investigate the performance and safety of the three 2-piece convex ostomy appliances

Official Title
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Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Coloplast Test 1
* Device: Coloplast Test 2
* Device: Coloplast Test 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects interested in participating in the clinical investigation must comply with the following criteria: Are at least 18 years of age and have full legal capacity Have had an ileostomy for at least 3 months. Have used a convex ostomy appliance for the last month Have given written informed consent Have an ileostomy with a diameter of 33mm or less Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks Exclusion Criteria: Subjects complying with the following criteria must be excluded from participation in the clinical investigation: Have a loop ostomy (also called double-barrel or ostomy with two outlets) Are pregnant* or breastfeeding. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)). Known hypersensitivity toward any of the test products -

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coloplast Test 1<br>The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2 Finally the all subject test Coloplast Test 3 | Device: Coloplast Test 1<br>* Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance<br>Device: Coloplast Test 2<br>* Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance<br>Device: Coloplast Test 3<br>* Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance<br>|
| Experimental: Coloplast Test 2<br>The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3 | Device: Coloplast Test 1<br>* Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance<br>Device: Coloplast Test 2<br>* Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance<br>Device: Coloplast Test 3<br>* Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Leakage | The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate) | 14 days |