Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Ileostomy - Stoma
Interventions
DEVICE

Coloplast test product

Coloplast test product is a newly developed 2-piece ostomy appliance

DEVICE

SenSura

SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S

Trial Locations (17)

2820

Imelda Hospital Bonheiden, Bonheiden

3050

Coloplast A/S, Humlebæk

3269

Helse Nordbyen, Larvik

5000

Stomiambulatoriet A5, Odense Hospital, Odense C

5504

Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus, Haugesund

5700

Kirurgisk ambulatorium/Stomiambulatoriet OUH, Svendborg

6000

Stomiambulatoriet, Kolding Sygehus, Kolding

6200

Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland, Aabenraa

7100

Vejle Sygehus, Stomiambulatoriet B120, Vejle

9713 GZ

QPS Netherlands, Groningen

801 87

Länssjukhhuset gävle, Stomimottagningen, Gävle

651 85

Kirug kliniken Centralsjukhuset, Karlstad

205 02

Kirurgens Mottagning, Malmo

112 45

Capio St. Görans Sjukhus AB, kirurgkliniken, Stockholm

117 61

Södersjukhuset, Stockholm

171 76

karolinska Universitetssjukhuset Solna Stomimottagningen, Stockholm

721 89

Stomimottagningen Centrllasarette i Västerås, Västerås

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY