Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
NCT ID: NCT01994863
Last Updated: 2015-03-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2012-09-30
2012-11-30
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
PREVENTION
NONE
Study Groups
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First Coloplast Test product; then Standard Care (see below)
The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
Coloplast Test product
Coloplast test product is a newly developed 1-piece ostomy appliance
Standard Care
Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
First Standard Care (see below); Then coloplast test product
The subjects are randomised to test Standard care first and thereafter test Coloplast test product.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
Coloplast Test product
Coloplast test product is a newly developed 1-piece ostomy appliance
Standard Care
Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Interventions
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Coloplast Test product
Coloplast test product is a newly developed 1-piece ostomy appliance
Standard Care
Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
4. Have an ileostomy with a diameter between 15 and 45 mm
5. Have had their ostomy for at least three months
6. Currently use a 1-piece flat product with open bag
7. Use minimum 1 product every second day.
8. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
9. Must use custom cut product
10. Accept to test two 1-piece products within the study
Exclusion Criteria
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
3. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Has more than three days wear time
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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Daniel Carter, MSc
Role: STUDY_DIRECTOR
Coloplast A/S
Locations
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QPS Netherland B.V.
Groningen, , Netherlands
Countries
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Other Identifiers
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CP224
Identifier Type: -
Identifier Source: org_study_id
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