NCT01994863View on ClinicalTrials.gov

Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

PHASE2TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Ileostomy - Stoma
Interventions
DEVICE

Coloplast Test product

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

DEVICE

Standard Care

"Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"

Trial Locations (1)

9713 GZ

QPS Netherland B.V., Groningen

Sponsors

Lead Sponsor

Coloplast A/S
All Listed Sponsors
lead

Coloplast A/S

INDUSTRY

NCT01994863 - Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy | Biotech Hunter | Biotech Hunter