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

Coloplast

Status: Terminated

Conditions: Fecal Incontinence

Treatments: Device: Fecal Incontinence Management System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556972

DK172OS

Details and patient eligibility

About

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.

Full description

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Fecal Incontinence management system

Experimental group

Description:

Fecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage.

Treatment:

Device: Fecal Incontinence Management System