Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
- Conditions
- Ileostomy - Stoma
- Interventions
- Device: Coloplast test productDevice: SenSura
- Registration Number
- NCT01957553
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
- Detailed Description
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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)
- 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
-
- 7.Known hypersensitivity towards any of the test products
- 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence 1, First Coloplast Test product SenSura Subjects first allocated to Coloplast Test product will after cross-over test SenSura Treatment seqence 2; First SenSura Coloplast test product Subjects first allocated to SenSura will after cross-over test Coloplast Test product Treatment sequence 1, First Coloplast Test product Coloplast test product Subjects first allocated to Coloplast Test product will after cross-over test SenSura Treatment seqence 2; First SenSura SenSura Subjects first allocated to SenSura will after cross-over test Coloplast Test product
- Primary Outcome Measures
Name Time Method Preference 21+1 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Helse Nordbyen
🇳🇴Larvik, Norway
Imelda Hospital Bonheiden
🇧🇪Bonheiden, Belgium
Vejle Sygehus, Stomiambulatoriet B120
🇩🇰Vejle, Denmark
QPS Netherlands
🇳🇱Groningen, Netherlands
Stomimottagningen Centrllasarette i Västerås
🇸🇪Västerås, Sweden
Länssjukhhuset gävle, Stomimottagningen
🇸🇪Gävle, Sweden
Kirug kliniken Centralsjukhuset
🇸🇪Karlstad, Sweden
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
Kirurgens Mottagning
🇸🇪Malmö, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
Capio St. Görans Sjukhus AB, kirurgkliniken
🇸🇪Stockholm, Sweden
karolinska Universitetssjukhuset Solna Stomimottagningen
🇸🇪Stockholm, Sweden
Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus
🇳🇴Haugesund, Norway