An Investigation of Ostomy Devices

Study Overview
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Brief Summary
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Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices. The secondary objective is to investigate several performance and safety parameters of the various devices. The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed. Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development. The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users. Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.

Official Title
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CP216: An Exploratory Investigation of Convex Ostomy Devices

Conditions
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Ileostomy

Intervention / Treatment
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* Device: Ostomy appliance: convex 1-piece drainable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years old Have signed the declaration of informed consent Have an ileostomy in a concave area Have had an ileostomy for at least three months Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month Be users of 1-piece or 2-piece open ostomy devices Have an ileostomy with a diameter of less than 33 mm Exclusion Criteria: Are pregnant or breast-feeding Have a double-loop ileostomy Have known hypersensitivity or allergy to the devices' component ingredients Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months. Are receiving/have received local peristomal or systemic steroid treatment within the last month Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm<br>The arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A*, B*, C*, D*. | Device: Ostomy appliance: convex 1-piece drainable<br>* 8 variations of an ostomy devices are tested<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 under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S | One week |