Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

Study Overview
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Brief Summary
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The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

Detailed Description
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The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.

Official Title
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Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.

Conditions
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Ileostomy - Stoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Have given written informed consent and letter of authority (DK only) 2.Be at least 18 years of age and have full legal capacity. 3.Be able to handle the products her/himself 4.Have an ileostomy with a diameter between 10 and 40 mm. 5.Have had their ostomy for at least three months. 6.Be willing to use minimum 2 base plates every week 7.Currently use 2-piece flat mechanical coupling product with open bag 8 11.Negative result of a pregnancy test for women of childbearing age (only DK) Exclusion Criteria: 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy. 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3.Is pregnant or breastfeeding. 4.Is participating in other interventional clinical investigations or have previously participated in this investigation 5.Has participated in the previous explorative study CP234 6. 7.Known hypersensitivity towards any of the test products 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)

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: Treatment sequence 1, First Coloplast Test product<br>Subjects first allocated to Coloplast Test product will after cross-over test SenSura | Device: Coloplast test product<br>* Coloplast test product is a newly developed 2-piece ostomy appliance<br>Device: SenSura<br>* SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S<br>* Other names: SenSura Standard 2-piece;|
| Experimental: Treatment seqence 2; First SenSura<br>Subjects first allocated to SenSura will after cross-over test Coloplast Test product | Device: Coloplast test product<br>* Coloplast test product is a newly developed 2-piece ostomy appliance<br>Device: SenSura<br>* SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S<br>* Other names: SenSura Standard 2-piece;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference | The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura. | 21+1 days |