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

November 15, 2022 updated by: Coloplast A/S
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Incontinence management system
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
The device is intended to remedy fecal incontinence.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is the Barrier Size and Shape Satisfactory
Time Frame: Subjects were followed for the duration of the study, an average of 23 hours
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
Time Frame: Subjects were evaluated before and after test
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?
Time Frame: After application of product
After application of product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Study Chair: Thais Benjamin N. Christensen, M.Sc. (BME), Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK172OS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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