Clinical trial NCT01957553: Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
Official title: Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click in 130 Subjects With an Ileostomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Preference
timeFrame: 21+1 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital Bonheiden
city: Aabenraa
country: Denmark
facility: Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland
city: Humlebæk
country: Denmark
facility: Coloplast A/S
city: Kolding
country: Denmark
facility: Stomiambulatoriet, Kolding Sygehus
city: Odense C
country: Denmark
facility: Stomiambulatoriet A5, Odense Hospital
city: Svenborg
country: Denmark
facility: Kirurgisk ambulatorium/Stomiambulatoriet OUH
city: Vejle
country: Denmark
facility: Vejle Sygehus, Stomiambulatoriet B120
city: Groningen
country: Netherlands
facility: QPS Netherlands
city: Haugesund
country: Norway
facility: Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus
city: Larvik
country: Norway
facility: Helse Nordbyen
city: Gävle
country: Sweden
facility: Länssjukhhuset gävle, Stomimottagningen
city: Karlstad
country: Sweden
facility: Kirug kliniken Centralsjukhuset
city: Malmö
country: Sweden
facility: Kirurgens Mottagning
city: Stockholm
country: Sweden
facility: Capio St. Görans Sjukhus AB, kirurgkliniken
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: karolinska Universitetssjukhuset Solna Stomimottagningen
city: Västerås
country: Sweden
facility: Stomimottagningen Centrllasarette i Västerås
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References: