An interventional study of Test A and Test B in Ostomy - Ileostomy or Colostomy, sponsored by Coloplast A/S. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-23.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
Exclusion Criteria:
Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator.
Device: Test A · Device: Test B · Device: Comparator
The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B.
Device: Test A · Device: Test B · Device: Comparator
The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator.
Device: Test A · Device: Test B · Device: Comparator
The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B.
Device: Test A · Device: Test B · Device: Comparator
The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B
Device: Test A · Device: Test B · Device: Comparator
The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A.
Device: Test A · Device: Test B · Device: Comparator
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
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.
Fit to body
Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?" The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.
Time frame: 14 +/- 2 days
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Coloplast A/S