A Feasibility Study of a Fecal Incontinence Management System for Medical Use - Full Text View

Sponsored by:	Coloplast A/S
Information provided by:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00556972

Purpose

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.

Condition	Intervention	Phase
Fecal Incontinence	Device: Fecal Incontinence Management System	Phase I Phase II

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment
Official Title:	A Feasibility Study of a Fecal Incontinence Management System for Medical Use

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:

The primary outcome measure is device weartime. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adhesive size and shape, Product handling, Flexibility, Skin evaluation [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	January 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: Fecal Incontinence Management System The device is intended to remedy fecal incontinence.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556972

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Coloplast A/S

Investigators

Study Chair:

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

Coloplast A/S

More Information

Responsible Party:	Coloplast A/S ( Thais Benjamin Nygaard Christensen/Clinical Trial Manager )
Study ID Numbers:	DK172OS, DK172OS
Study First Received:	November 9, 2007
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00556972
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Urination Disorders

Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 15, 2009