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

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
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 October 29, 2008

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