Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
NCT ID: NCT01957462
Last Updated: 2016-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2013-04-30
2013-05-31
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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FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
Coloplast Test V
Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X
Coloplast Test X is a newly developed 1-piece ostomy appliance
First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
Coloplast Test V
Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X
Coloplast Test X is a newly developed 1-piece ostomy appliance
Interventions
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Coloplast Test V
Coloplast Test product V is a newly developed 1-piece ostomy appliance
Coloplast Test X
Coloplast Test X is a newly developed 1-piece ostomy appliance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ostomy (ileo- or colostomy) for at least 3 months.
4. Have used a 1-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have a ostomy with a diameter of 33 mm or less.
Exclusion Criteria
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Use irrigation during the investigation (flush the stoma with water).
8. Participating in other interventional clinical investigations or have previously participated in this 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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Birte P Jakobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Coloplast A/S
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP239
Identifier Type: -
Identifier Source: org_study_id
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