Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Ileostomy - Stoma
Interventions
DEVICE

Coloplast Test product 1

Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.

DEVICE

Coloplast Test product 2

Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S

DEVICE

Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

"Standard Care was the subject usual ostomy appliance and had to be one of the following:~* Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut,~* Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate~* Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate~* ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate~* B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate"

Trial Locations (1)

Unknown

Coloplast A/S, Humlebæk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT01957384 - Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care | Biotech Hunter | Biotech Hunter