Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

Study Overview
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Brief Summary
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This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.

Official Title
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Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

Conditions
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Ileostomy, Colostomy

Intervention / Treatment
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* Device: Coloplast Test A
* Device: Coloplast Test B
* Device: Subjects own product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures. Exclusion Criteria: Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. Are pregnant or breastfeeding** Are participating in other interventional clinical investigations or have previously participated in this investigation Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy) Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) Have a loop ostomy (also called double barrel ostomy) Have known hypersensitivity towards any of the products used in the investigation In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.

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: Test A, Test B, Subjects own product<br>The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product | Device: Coloplast Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Subjects own product<br>* The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.<br>|
| Experimental: Test A, Subjects own product, Test B<br>The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B | Device: Coloplast Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Subjects own product<br>* The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.<br>|
| Experimental: Test B, Test A, Subjects own product<br>The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product | Device: Coloplast Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Subjects own product<br>* The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.<br>|
| Experimental: Test B, Subjects own product, Test A<br>The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A | Device: Coloplast Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Subjects own product<br>* The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.<br>|
| Experimental: Subjects own product, Test A, Test B<br>The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B | Device: Coloplast Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Subjects own product<br>* The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.<br>|
| Experimental: Subjects own product, Test B, Test A<br>The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A | Device: Coloplast Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Coloplast Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Subjects own product<br>* The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit to Body | Subjects will evaluate the fit to body for each product by answering the question how was the baseplates ability to fit the body contours in the area around the stoma? The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question. | 14 +/- 2 days |