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

November 9, 2007
November 29, 2012
January 2008
April 2008   (final data collection date for primary outcome measure)
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 ]
The primary outcome measure is device weartime. [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00556972 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
A Feasibility Study of a Fecal Incontinence Management System for Medical Use

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.

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

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Fecal Incontinence
Device: Fecal Incontinence Management System
The device is intended to remedy fecal incontinence.
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.
Intervention: Device: Fecal Incontinence Management System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
April 2008
April 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00556972
DK172OS
No
Coloplast A/S
Coloplast A/S
Not Provided
Study Chair: Thais Benjamin N. Christensen, M.Sc. (BME) Coloplast A/S
Coloplast A/S
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP