A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:September 2015
End Date:March 2016

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The aim of the study is to obtain an understanding of relevant parameters affecting the
performance of ostomy products.


Inclusion Criteria:

- Have given written informed consent

- Be at least 18 years of age and have full legal capacity

- Have an ileostomy or colostomy

- Have had their ostomy for at least 3 months

- Must use 1 piece open or closed ostomy products during the test period

- Currently using a 1 piece. flat product

- Must be able to use custom cut product

- Have intact peristomal skin

- Has experienced leakage (seeping) under the baseplate at least three times during the
last two weeks

- Are evaluated to be suitable for a soft convex product

Exclusion Criteria:

- Currently receiving or have within the past 2 month received radio- and/or
chemotherapy

- Currently or having within the past month received topical steroid treatment in the
peristomal skin area or systemic steroid (tablet/injection) treatment.

- Are pregnant or breastfeeding

- Participating in other interventional clinical investigations or have previously
participated in this investigation
We found this trial at
3
sites
Groningen,
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Groningen,
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Chicago, Illinois 60637
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Chicago, IL
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1000 Westgate Drive
Saint Paul, Minnesota 55114
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Saint Paul, MN
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