A Feasibility Study of a Fecal Incontinence Management System for Medical Use
NCT ID: NCT00556972
Last Updated: 2022-12-06
Study Results
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View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2008-01-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Fecal Incontinence Management System
The device is intended to remedy fecal incontinence.
Interventions
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Fecal Incontinence Management System
The device is intended to remedy fecal incontinence.
Eligibility Criteria
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Inclusion Criteria
* The subject has fecal incontinence
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Thais Benjamin N. Christensen, M.Sc. (BME)
Role: STUDY_CHAIR
Coloplast A/S
Locations
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Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, United States
Countries
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Other Identifiers
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DK172OS
Identifier Type: -
Identifier Source: org_study_id
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