Expired Study
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Boston, Massachusetts 02215


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.


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 is Available At:

Original ID:




Secondary ID:


Study Acronym:

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

Overall Status:


Study Phase:

Phase 1/Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Coloplast A/S

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Due to numerous delays in study start-up pro

Study Type:


Study Design:

Intervention Model: Single Group Assignment, Mask

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:January 2008
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:April 2008
Last Changed Date:April 23, 2008
First Received Date:November 9, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary outcome measure is device weartime.
Time Frame:5 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Adhesive size and shape, Product handling, Flexibility, Skin evaluation
Time Frame:5 days
Safety Issues:True

Study Interventions

Intervention Type:Device
Name:Fecal Incontinence Management System
Description:The device is intended to remedy fecal incontinence.
Arm Name:A

Study Arms

Study Arm Type:Experimental
Arm Name:A

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Coloplast A/S

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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