Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
NCT ID: NCT02675634
Last Updated: 2017-10-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2016-01-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Test A, Test B, Subjects own product
The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product
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.
Test A, Subjects own product, Test B
The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B
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.
Test B, Test A, Subjects own product
The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product
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.
Test B, Subjects own product, Test A
The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A
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.
Subjects own product, Test A, Test B
The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B
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.
Subjects own product, Test B, Test A
The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Camilla F Vibjerg
Role: STUDY_CHAIR
Head of Clinical Operation
Locations
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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
Countries
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Other Identifiers
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CP266
Identifier Type: -
Identifier Source: org_study_id