Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

NACompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Ileostomy - Stoma
Interventions
DEVICE

Coloplast Test Product 1

Coloplast Test product 1 is a newly developed 1-piece ostomy appliance

DEVICE

Coloplast Test Product 2

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

DEVICE

Coloplast SenSura

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Trial Locations (4)

3050

Holtedam 3, Humlebæk

3269

Sykepleierklinikken, Larvik

9713

QPS Nederlands, Groningen

PR71NY

Synexus Limited, Chorley

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT01957488 - Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece | Biotech Hunter | Biotech Hunter