A Feasibility Study of a Fecal Incontinence Management System for Medical Use
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|ClinicalTrials.gov Identifier: NCT00556972|
Recruitment Status : Terminated (Due to numerous delays in study start-up process...)
First Posted : November 12, 2007
Results First Posted : January 1, 2013
Last Update Posted : January 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: Fecal Incontinence Management System||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Study of a Fecal Incontinence Management System for Medical Use|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
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.
- The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) [ Time Frame: 5 days ]
- Is the Barrier Size and Shape Satisfactory [ Time Frame: Subjects were followed for the duration of the study, an average of 23 hours ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556972
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center, Inc.|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Thais Benjamin N. Christensen, M.Sc. (BME)||Coloplast A/S|