Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

Study Overview
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Brief Summary
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The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.

Official Title
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An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: Coloplast Test product
* Device: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Be able to handle the appliance themselves or with help from caregiver (e.g. spouse) Have an ileostomy with a diameter between 15 and 45 mm Have had their ostomy for at least three months Currently use a 1-piece flat product with open bag Use minimum 1 product every second day. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate Must use custom cut product Accept to test two 1-piece products within the study Exclusion Criteria: Use irrigation during the study (flush the stoma with water) Currently receiving or have within the past 2 months received radio- and/or chemotherapy Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participated in this investigation Has more than three days wear time

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Coloplast Test product; then Standard Care (see below)<br>The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. | Device: Coloplast Test product<br>* Coloplast test product is a newly developed 1-piece ostomy appliance<br>* Other names: Coloplast 1-piece test product;Device: Standard Care<br>* Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima<br>* Other names: B.Braun Flexima/Softima;|
| Experimental: First Standard Care (see below); Then coloplast test product<br>The subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. | Device: Coloplast Test product<br>* Coloplast test product is a newly developed 1-piece ostomy appliance<br>* Other names: Coloplast 1-piece test product;Device: Standard Care<br>* Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima<br>* Other names: B.Braun Flexima/Softima;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage | The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. | 14+/-3 days per product |