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

Not Applicable

Completed

Conditions: Colostomy
Ileostomy

Interventions: Device: Coloplast Test A
Device: Coloplast Test B
Device: Subjects own product

Registration Number: NCT02675634

Lead Sponsor: Coloplast A/S

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

Inclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fit to Body	14 +/- 2 days	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (12): Prism research center
🇺🇸
Saint Paul, Minnesota, United States
Synexus Midlands
🇬🇧
Birmingham, United Kingdom
Kettering General hospital
🇬🇧
Northamptonshire, United Kingdom
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
TFS
🇩🇰
Søborg, Denmark
Lincon Country hospital
🇬🇧
Lincoln, United Kingdom
Synexus Hexam
🇬🇧
Northumberland, United Kingdom
QPS Netherlands
🇳🇱
Groningen, Netherlands
Pilgrim Hospital
🇬🇧
Boston, United Kingdom
Aintree University Hospital NHS Foundation Trust
🇬🇧
Liverpool, United Kingdom
Illingworth Research Nurses
🇬🇧
Cheshire, United Kingdom
Radiant Research
🇺🇸
Tempe, Arizona, United States