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

Colostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675634
• Other study ID #: CP266
• Status: Completed
• Phase: N/A
• First received: January 29, 2016
• Last updated: September 14, 2017
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: September 2017
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colostomy
• Ileostomy

Intervention

Device:
• Coloplast Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
• Coloplast Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
• Subjects own product
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.

Locations

Country	Name	City	State
Denmark	TFS	Søborg
Netherlands	QPS Netherlands	Groningen
United Kingdom	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 States	Cleveland Clinic	Cleveland	Ohio
United States	Prism research center	Saint Paul	Minnesota
United States	Radiant Research	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Denmark,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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