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

Coloplast

Status: Completed

Conditions: Colostomy; Ileostomy

Treatments: Device: Coloplast Test B; Device: Subjects own product; Device: Coloplast Test A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02675634

CP266

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. 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)

2. 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.

3. Are pregnant or breastfeeding**

4. Are participating in other interventional clinical investigations or have previously participated in this investigation

5. Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)

6. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)

7. Have a loop ostomy (also called double barrel ostomy)

8. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 6 patient groups

Test A, Test B, Subjects own product

Experimental group

Description:

The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product

Treatment:

Device: Coloplast Test B

Device: Subjects own product

Device: Coloplast Test A

Test A, Subjects own product, Test B

Experimental group

Description:

The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B

Treatment:

Device: Coloplast Test B

Device: Subjects own product

Device: Coloplast Test A

Test B, Test A, Subjects own product

Experimental group

Description:

The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product

Treatment:

Device: Coloplast Test B

Device: Subjects own product

Device: Coloplast Test A

Test B, Subjects own product, Test A

Experimental group

Description:

The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A

Treatment:

Device: Coloplast Test B

Device: Subjects own product

Device: Coloplast Test A

Subjects own product, Test A, Test B

Experimental group

Description:

The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B

Treatment:

Device: Coloplast Test B

Device: Subjects own product

Device: Coloplast Test A

Subjects own product, Test B, Test A

Experimental group

Description:

The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A

Treatment:

Device: Coloplast Test B

Device: Subjects own product

Device: Coloplast Test A