The Influence of Adhesive Wafer Design on Fit to the Body

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

March 31, 2015

Conditions
Ostomy - Ileostomy or Colostomy
Interventions
DEVICE

Test A

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

DEVICE

Test B

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

DEVICE

Comparator

"Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.~Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed."

Trial Locations (10)

9713

QPS Netherlands, Groningen

RG2 0TG

Synexus Thames Valley, Berkshire

B15 2SQ

Synexus Midlands, Birmingham

CF14 5GJ

Synexus Wales, Cardiff

G20 0SP

Synexus Scotland, Glasgow

G1537AN

Cheltenham General Hospital, Gloucestershire

PR7 7NA

Synesxus Lancashire, Lancashire

L22 0LG

Synexus Merseyside, Liverpool

M15 6SX

Synexus Manchester, Manchester

NE46 1QJ

Synexus North East, Northumberland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY