Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

NACompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Subjects With an Ileostomy
Interventions
DEVICE

Coloplast A

Coloplast A is a newly developed 2-piece ostomy appliance

DEVICE

Coloplast B

Coloplast B is a newly developed 2-piece ostomy appliance

DEVICE

Coloplast C

Coloplast C is a newly developed 2-piece ostomy appliance

DEVICE

SenSura Click

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Trial Locations (1)

3050

Coloplast A/S, Humlebæk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT01800890 - Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy | Biotech Hunter | Biotech Hunter