This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
55
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
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.
Radiant Research
Tempe, Arizona, United States
Prism research center
Saint Paul, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Fit to Body
Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.
Time frame: 14 +/- 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
TFS
Søborg, Denmark
QPS Netherlands
Groningen, Netherlands
Synexus Midlands
Birmingham, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Illingworth Research Nurses
Cheshire, United Kingdom
Lincon Country hospital
Lincoln, United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, United Kingdom
...and 2 more locations