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Feasibility Study of a New Fistula Pouching System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294450
First Posted: February 22, 2006
Last Update Posted: February 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coloplast A/S
  Purpose
The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.

Condition Intervention Phase
Cutaneous Fistula Device: Fistula Pouching System Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pouching of Fistula - a Non-comparative, Multi-center Investigation

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Nurse's preference to use the test product in the future [ Time Frame: Up to 18 days ]

Enrollment: 22
Study Start Date: February 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fistula Pouching System
    3 different sizes of fistula pounching system
    Other Name: Fistula and Wound Management System
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Capable of giving informed consent
  • Have to be hospitalized
  • Have a fistula with the opening on the skin in the abdominal area

Exclusion Criteria:

  • Pregnant and/or breast-feeding
  • Receiving radiation- or chemotherapy during the investigation period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294450


Locations
United States, Connecticut
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
Morton Plant Hospital
Clearwarter, Florida, United States, 33756
United States, Minnesota
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
University of Minnesota Medical Center Fairview - Riverside
Minneapolis, Minnesota, United States, 55454
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Coloplast A/S
Investigators
Study Chair: Thais Benjamin N. Christensen, M.Sc. (BME) Coloplast A/S
  More Information

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00294450     History of Changes
Other Study ID Numbers: DK140OS
First Submitted: February 20, 2006
First Posted: February 22, 2006
Last Update Posted: February 1, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Fistula
Cutaneous Fistula
Pathological Conditions, Anatomical
Skin Diseases