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

This study has been terminated.
(Due to numerous delays in study start-up process...)
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00556972
First received: November 9, 2007
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  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 1
Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Is the Barrier Size and Shape Satisfactory [ Time Frame: Subjects were followed for the duration of the study, an average of 23 hours ] [ Designated as safety issue: No ]
    Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory

  • Assessment of Skin 0-2 Inches From the Edge of the Anus [ Time Frame: Subjects were evaluated before and after test ] [ Designated as safety issue: Yes ]
    Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.

  • What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? [ Time Frame: After application of product ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Device: Fecal Incontinence Management System
The device is intended to remedy fecal incontinence.

Detailed 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

  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

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00556972     History of Changes
Other Study ID Numbers: DK172OS
Study First Received: November 9, 2007
Results First Received: August 2, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013