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

Study Overview
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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

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Fecal Incontinence Management System


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Incontinence management system<br>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<br>* The device is intended to remedy fecal incontinence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is the Barrier Size and Shape Satisfactory | Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory | Subjects were followed for the duration of the study, an average of 23 hours | 
| Assessment of Skin 0-2 Inches From the Edge of the Anus | 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. | Subjects were evaluated before and after test | 
| What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? |  | After application of product |