Feasibility Study of a New Fistula Pouching System - Full Text View

Sponsored by:	Coloplast A/S
Information provided by:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00294450

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 II Phase III

MedlinePlus related topics: Fistulas

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Mease Countryside Hospital
Safety Harbor, Florida, United States, 34695
North Bay Hospital
New Port Richey, Florida, United States, 34652
Mease Dunedin Hospital
Dunedin, Florida, United States, 34698
United States, Minnesota
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
University of Minnesota Medical Center Fairview - Riverside
Minneapolis, Minnesota, United States, 55454
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

Study ID Numbers:	DK140OS
Study First Received:	February 20, 2006
Last Updated:	July 3, 2007
ClinicalTrials.gov Identifier:	NCT00294450
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Skin Diseases
Cutaneous Fistula
Fistula

ClinicalTrials.gov processed this record on January 16, 2009