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

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.

Study Overview

• Status: Completed
• Conditions: Colostomy; Ileostomy
• Intervention / Treatment: Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Søborg, Denmark, 2860
    • TFS
• Netherlands
  • Groningen, Netherlands, 9713
    • QPS Netherlands
• United Kingdom
  • Birmingham, United Kingdom, B15 2SQ
    • Synexus Midlands
  • Boston, United Kingdom
    • Pilgrim Hospital
  • Cheshire, United Kingdom, Sk11 6TG
    • Illingworth Research Nurses
  • Lincoln, United Kingdom, LN25QY
    • Lincon Country hospital
  • Liverpool, United Kingdom, L9 7AL
    • Aintree University Hospital NHS Foundation Trust
  • Northamptonshire, United Kingdom, NN168UZ
    • Kettering General Hospital
  • Northumberland, United Kingdom, NE46 1QJ
    • Synexus Hexam
• United States
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Radiant Research
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • PRISM Research Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Chair: Camilla F Vibjerg, Head of clinical operation

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CP266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO