Ileostomy - Stoma Clinical Trial
Official title:
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
Verified date | September 2014 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Health and Medicines Authority |
Study type | Interventional |
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
Status | Completed |
Enrollment | 130 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 1.Have given written informed consent and letter of authority (DK only) - 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: - 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy. - 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Belgium | Imelda Hospital Bonheiden | Bonheiden | |
Denmark | 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 | Svenborg | |
Denmark | Vejle Sygehus, Stomiambulatoriet B120 | Vejle | |
Netherlands | QPS Netherlands | Groningen | |
Norway | Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus | Haugesund | |
Norway | Helse Nordbyen | Larvik | |
Sweden | Länssjukhhuset gävle, Stomimottagningen | Gävle | |
Sweden | Kirug kliniken Centralsjukhuset | Karlstad | |
Sweden | Kirurgens Mottagning | Malmö | |
Sweden | Capio St. Görans Sjukhus AB, kirurgkliniken | Stockholm | |
Sweden | karolinska Universitetssjukhuset Solna Stomimottagningen | Stockholm | |
Sweden | Södersjukhuset | Stockholm | |
Sweden | Stomimottagningen Centrllasarette i Västerås | Västerås |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Belgium, Denmark, Netherlands, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preference | The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura. | 21+1 days | No |
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