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

• ClinicalTrials.gov Identifier: NCT02675634
• Recruitment Status: Completed
• First Posted: February 5, 2016
• Results First Posted: September 5, 2017
• Last Update Posted: October 16, 2017
• Sponsor: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ileostomy; Colostomy	Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
• Study Start Date: January 2016
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test A, Test B, Subjects own product; The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Test A, Subjects own product, Test B; The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Test B, Test A, Subjects own product; The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Test B, Subjects own product, Test A; The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Subjects own product, Test A, Test B; The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Subjects own product, Test B, Test A; The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Fit to Body [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Radiant Research

Tempe, Arizona, United States, 85282

United States, Minnesota

Prism research center

Saint Paul, Minnesota, United States, 55114

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Denmark

TFS

Søborg, Denmark, 2860

Netherlands

QPS Netherlands

Groningen, Netherlands, 9713

United Kingdom

Synexus Midlands

Birmingham, United Kingdom, B15 2SQ

Pilgrim Hospital

Boston, United Kingdom

Illingworth Research Nurses

Cheshire, United Kingdom, Sk11 6TG

Lincon Country hospital

Lincoln, United Kingdom, LN25QY

Aintree University Hospital NHS Foundation Trust

Liverpool, United Kingdom, l9 7AL

Kettering General hospital

Northamptonshire, United Kingdom, NN168UZ

Synexus Hexam

Northumberland, United Kingdom, NE46 1QJ

Sponsors and Collaborators

Coloplast A/S

Investigators

• Study Chair: Camilla F Vibjerg; Head of Clinical Operation

More Information

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT02675634
• Other Study ID Numbers: CP266
• First Posted: February 5, 2016
• Results First Posted: September 5, 2017
• Last Update Posted: October 16, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No