Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

PHASE3TerminatedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
LeakageSkin Condition
Interventions
DEVICE

New ostomy base plate (SS)

The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

DEVICE

Standard Care base plate

The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.

Trial Locations (11)

108

Landspitali University Hospital, Reykjavik

2400

Bispebjerg Hospital, Copenhagen

2650

Hvidovre Hospital, Hvidovre

5000

Odense Universitetshospital, Odense

6200

Sygehus Sønderjylland i Aabenraa, Aabenraa

13015

Hôpital Nord, Marseille

35033

Hôpital de Pontchaillou, CHRU de Rennes, Rennes

44093

Hôpital Hôtel Dieu de Nantes, Nantes

75475

Hôpital Lariboisière, Paris

86021

CHRU La Milétrie, Poitiers

94032

Sanitätshaus Fürst GmbH, Passau

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT01517178 - Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care | Biotech Hunter | Biotech Hunter