Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
NCT ID: NCT01957553
Last Updated: 2014-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2013-09-30
2013-12-31
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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Treatment sequence 1, First Coloplast Test product
Subjects first allocated to Coloplast Test product will after cross-over test SenSura
Coloplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance
SenSura
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
Treatment seqence 2; First SenSura
Subjects first allocated to SenSura will after cross-over test Coloplast Test product
Coloplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance
SenSura
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
Interventions
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Coloplast test product
Coloplast test product is a newly developed 2-piece ostomy appliance
SenSura
SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
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 products her/himself
* 4.Have an ileostomy with a diameter between 10 and 40 mm.
* 5.Have had their ostomy for at least three months.
* 6.Be willing to use minimum 2 base plates every week
* 7.Currently use 2-piece flat mechanical coupling product with open bag 8
* 11.Negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion Criteria
* 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* 3.Is pregnant or breastfeeding.
* 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
* 5.Has participated in the previous explorative study CP234
* 6\.
* 7.Known hypersensitivity towards any of the test products
* 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
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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Imelda Hospital Bonheiden
Bonheiden, , Belgium
Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland
Aabenraa, , Denmark
Coloplast A/S
Humlebæk, , Denmark
Stomiambulatoriet, Kolding Sygehus
Kolding, , Denmark
Stomiambulatoriet A5, Odense Hospital
Odense C, , Denmark
Kirurgisk ambulatorium/Stomiambulatoriet OUH
Svendborg, , Denmark
Vejle Sygehus, Stomiambulatoriet B120
Vejle, , Denmark
QPS Netherlands
Groningen, , Netherlands
Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus
Haugesund, , Norway
Helse Nordbyen
Larvik, , Norway
Länssjukhhuset gävle, Stomimottagningen
Gävle, , Sweden
Kirug kliniken Centralsjukhuset
Karlstad, , Sweden
Kirurgens Mottagning
Malmo, , Sweden
Capio St. Görans Sjukhus AB, kirurgkliniken
Stockholm, , Sweden
Södersjukhuset
Stockholm, , Sweden
karolinska Universitetssjukhuset Solna Stomimottagningen
Stockholm, , Sweden
Stomimottagningen Centrllasarette i Västerås
Västerås, , Sweden
Countries
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Other Identifiers
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CP243
Identifier Type: -
Identifier Source: org_study_id
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