Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

NACompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
IleostomyColostomy
Interventions
DEVICE

Coloplast Test A

Test A is a new 1-piece ostomy appliance developed by Coloplast A/S

DEVICE

Coloplast Test B

Test B is a new 1-piece ostomy appliance developed by Coloplast A/S

DEVICE

Subjects own product

The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.

Trial Locations (12)

2860

TFS, Søborg

9713

QPS Netherlands, Groningen

44195

Cleveland Clinic, Cleveland

55114

Prism research center, Saint Paul

85282

Radiant Research, Tempe

B15 2SQ

Synexus Midlands, Birmingham

Unknown

Pilgrim Hospital, Boston

Sk11 6TG

Illingworth Research Nurses, Cheshire

LN25QY

Lincon Country hospital, Lincoln

l9 7AL

Aintree University Hospital NHS Foundation Trust, Liverpool

NN168UZ

Kettering General hospital, Northamptonshire

NE46 1QJ

Synexus Hexam, Northumberland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY