A Feasibility Study of a Fecal Incontinence Management System for Medical Use

Stopped early · Not applicable

Conditions studied: Fecal Incontinence

In brief

The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.

Key facts

Study ID

NCT00556972

Run by

Coloplast A/S

People needed

4

Starts

2008-01-01

Expected to finish

2008-04-01

Last updated by the study team

2022-12-06

Who can join

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

You may qualify if…

• The subject is at least 18 years of age
• The subject has fecal incontinence

You may not qualify if…

• The subject is pregnant and/or breastfeeding
• The subject has perianal fistulas and/or hemorrhoids
• It's estimated that the subject's perianal skin makes it inappropriate for subject to participate in the study (i.e. in case of damaged skin, very sweaty skin or very sinuous and folded skin)

Where it is running

• Beth Israel Deaconess Medical Center, Inc. — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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