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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00556972
• Other study ID #: DK172OS
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Fecal Incontinence

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