Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

NACompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
IleostomyColostomy
Interventions
DEVICE

Coloplast Test Product

A new 2-piece ostomy appliance developed by Coloplast A/S

DEVICE

Comparator (Hollister)

Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.

Trial Locations (5)

2860

Trial Form Support ApS (TFS), Soeborg

3269

Sykepleierklinikken A/S, Larvik, Larvik

12203

Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie, Berlin

22045

SIEWA Coloplast Homecare, Hamburg

9713G12

QPS Netherlands, Groningen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT02362360 - Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy | Biotech Hunter | Biotech Hunter