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Feasibility Study of a New Fistula Pouching System

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.
ClinicalTrials.gov Identifier: NCT00294450
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : February 1, 2012
Information provided by (Responsible Party):
Coloplast A/S

February 20, 2006
February 22, 2006
February 1, 2012
February 2006
March 2007   (Final data collection date for primary outcome measure)
Nurse's preference to use the test product in the future [ Time Frame: Up to 18 days ]
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Complete list of historical versions of study NCT00294450 on ClinicalTrials.gov Archive Site
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Feasibility Study of a New Fistula Pouching System
Pouching of Fistula - a Non-comparative, Multi-center Investigation
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.
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Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cutaneous Fistula
Device: Fistula Pouching System
3 different sizes of fistula pounching system
Other Name: Fistula and Wound Management System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2007
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Coloplast A/S
Coloplast A/S
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Study Chair: Thais Benjamin N. Christensen, M.Sc. (BME) Coloplast A/S
Coloplast A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP