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

NCT ID: NCT00556972

Last Updated: 2022-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Fecal Incontinence management system

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

Group Type EXPERIMENTAL

Fecal Incontinence Management System

Intervention Type DEVICE

The device is intended to remedy fecal incontinence.

Interventions

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Fecal Incontinence Management System

The device is intended to remedy fecal incontinence.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thais Benjamin N. Christensen, M.Sc. (BME)

Role: STUDY_CHAIR

Coloplast A/S

Locations

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Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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DK172OS

Identifier Type: -

Identifier Source: org_study_id

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