Fecal Incontinence Clinical Trial
Official title:
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
NCT number | NCT00556972 |
Other study ID # | DK172OS |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | April 2008 |
Verified date | November 2022 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center, Inc. | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) | 5 days | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | After application of product |
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