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

Completed · Not applicable

Conditions studied: Ileostomy - Stoma, Colostomy

In brief

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

Key facts

Study ID

NCT02517541

Run by

Coloplast A/S

People needed

74

Starts

2015-09-01

Expected to finish

2016-03-01

Last updated by the study team

2022-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Chicago Medicine — Chicago, Illinois, United States
• Prism research center — Saint Paul, Minnesota, United States
• QPS Netherlands — Groningen, Netherlands
• Helse Nordbyen — Larvik, Norway
• Synexus Midlands — Birmingham, United Kingdom
• Pilgrim Hospital — Boston, United Kingdom
• Cheltenham General Hospital — Cheltenham, United Kingdom
• Kettering General hospital — Kettering, United Kingdom
• Lincon Country hospital — Lincoln, United Kingdom

Full record on ClinicalTrials.gov

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