Back to resultsA Feasibility Study of a Fecal Incontinence Management System for Medical Use
Primary Purpose
Fecal Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Incontinence Management System
Sponsored by
About this trial
This is an interventional supportive care trial for Fecal Incontinence
Eligibility Criteria
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)
Sites / Locations
- Beth Israel Deaconess Medical Center, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fecal Incontinence management system
Arm Description
Fecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage.
Outcomes
Primary Outcome Measures
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Secondary Outcome Measures
Is the Barrier Size and Shape Satisfactory
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
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?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00556972
Brief Title
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
Official Title
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to numerous delays in study start-up process...
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal Incontinence management system
Arm Type
Experimental
Arm Description
Fecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage.
Intervention Type
Device
Intervention Name(s)
Fecal Incontinence Management System
Intervention Description
The device is intended to remedy fecal incontinence.
Primary Outcome Measure Information:
Title
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Is the Barrier Size and Shape Satisfactory
Description
Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory
Time Frame
Subjects were followed for the duration of the study, an average of 23 hours
Title
Assessment of Skin 0-2 Inches From the Edge of the Anus
Description
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.
Time Frame
Subjects were evaluated before and after test
Title
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Time Frame
After application of product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Benjamin N. Christensen, M.Sc. (BME)
Organizational Affiliation
Coloplast A/S
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
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