Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

Study Overview
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Brief Summary
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To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

Official Title
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Investigation of Newly Developed 1-piece Convex Baseplates 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must comply with the following criteria in order to participate in the investigation: 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 33 mm or less Have experience 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 (adreno-cortical hormone) in the peristomal area Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)) Are currently participating in another clinical investigation or has previously participated in this investigation

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: First Coloplast Test 1<br>The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2 | Device: Coloplast Test 1<br>* Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance<br>Device: Coloplast Test 2<br>* Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance<br>|
| Experimental: First Coloplast Test 2<br>The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1 | Device: Coloplast Test 1<br>* Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance<br>Device: Coloplast Test 2<br>* Coloplast Test 2 is a newly developed 1-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 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate) | 14 days |