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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date November 2022
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fecal Incontinence Management System
The device is intended to remedy fecal incontinence.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center, Inc. Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

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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