Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

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 Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.

Conditions
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Stoma Ileostomy

Intervention / Treatment
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* Device: Coloplast test product
* Device: SenSura Convex Light


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. Has had an ileostomy for at least 3 months. Has used a convex ostomy product for the last month. Has given signed informed consent. Has experienced seeping under the baseplate at least three times during the last two weeks. Currently using a SenSura Convex product with midi, maxi or magnum bags. Currently using a 1-piece product or a 2-piece product with a mechanical coupling (click coupling). Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less. Exclusion Criteria: Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets). Are pregnant or breastfeeding. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin. Are currently participating in another clinical intervention study or have previously participated in this one. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate. Has known hypersensitivity toward the test product.

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 product<br>The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light | Device: Coloplast test product<br>* The Coloplast test product is a newly developed ostomy appliance<br>Device: SenSura Convex Light<br>* The comparator product is SenSura Convex Light, which is CE-marked and commercially available.<br>* Other names: SenSura;|
| Experimental: First SenSura Convex Light<br>The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product | Device: Coloplast test product<br>* The Coloplast test product is a newly developed ostomy appliance<br>Device: SenSura Convex Light<br>* The comparator product is SenSura Convex Light, which is CE-marked and commercially available.<br>* Other names: SenSura;|

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 measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate). | 28 +/- 3 days |