Investigation of a New 1-piece Convex Ostomy Product

Study Overview
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Brief Summary
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The aim of the investigation was to investigate the performance and safety of a new ostomy product

Official Title
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Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy

Conditions
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Stoma Ileostomy, Stoma Colostomy

Intervention / Treatment
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* Device: Coloplast Test
* Device: Own product
* Device: Competitor soft convex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are at least 18 years of age and have full legal capacity. Have had an ileostomy/colostomy for more than 3 months Have used a 1-piece flat ostomy product for the last 1 month Has given written Informed Consent and signed the letter of authority Have an ileostomy or colostomy with a diameter of 33 mm or less Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks Are evaluated to be suitable for a soft convex product If having a colostomy: changes their product on average 2 times pr. 24h or more Currently uses a bag of size medi/midi or maxi Exclusion Criteria: Have a loop ostomy (also called double-barrel or ostomy with two outlets). Are pregnant or breastfeeding Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). Known hypersensitivity toward any of the test products Participating in other interventional clinical investigations or have previously participated in this investigation Use irrigation during the investigation (flush the intestine with water) Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate If subject has a colostomy: empties the bag

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<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either Own product (baseline) Competitor soft convex | Device: Coloplast Test<br>* Newly developed 1-piece convex ostomy product<br>Device: Own product<br>* The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.<br>Device: Competitor soft convex<br>* A commercially available soft convex product<br>|
| Experimental: First Competitor soft convex<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either Own product (baseline) Coloplast Test | Device: Coloplast Test<br>* Newly developed 1-piece convex ostomy product<br>Device: Own product<br>* The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.<br>Device: Competitor soft convex<br>* A commercially available soft convex product<br>|
| Experimental: First Own product<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either Coloplast Test Competitor soft convex | Device: Coloplast Test<br>* Newly developed 1-piece convex ostomy product<br>Device: Own product<br>* The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.<br>Device: Competitor soft convex<br>* A commercially available soft convex product<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 is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage. | 14 +/- 3 days |