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

Completed · Not applicable

Conditions studied: Ileostomy, Colostomy

In brief

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.

Key facts

Study ID

NCT02675634

Run by

Coloplast A/S

People needed

55

Starts

2016-01-01

Expected to finish

2016-06-01

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Radiant Research — Tempe, Arizona, United States
• Prism research center — Saint Paul, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• TFS — Søborg, Denmark
• QPS Netherlands — Groningen, Netherlands
• Synexus Midlands — Birmingham, United Kingdom
• Pilgrim Hospital — Boston, United Kingdom
• Illingworth Research Nurses — Cheshire, United Kingdom
• Lincon Country hospital — Lincoln, United Kingdom
• Aintree University Hospital NHS Foundation Trust — Liverpool, United Kingdom
• Kettering General hospital — Northamptonshire, United Kingdom
• Synexus Hexam — Northumberland, United Kingdom

Full record on ClinicalTrials.gov

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