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Feasibility Study of a New Fistula Pouching System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00294450
First received: February 20, 2006
Last updated: January 31, 2012
Last verified: January 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
United States, Minnesota
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
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

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00294450     History of Changes
Other Study ID Numbers: DK140OS
Study First Received: February 20, 2006
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014