Status:

COMPLETED

Feasibility Study of a New Fistula Pouching System

Lead Sponsor:

Coloplast A/S

Conditions:

Cutaneous Fistula

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • Pregnant and/or breast-feeding
  • Receiving radiation- or chemotherapy during the investigation period

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2007

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT00294450

Start Date

February 1 2006

End Date

March 1 2007

Last Update

February 1 2012

Active Locations (7)

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Page 1 of 2 (7 locations)

1

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States, 06105

2

Morton Plant Hospital

Clearwarter, Florida, United States, 33756

3

Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

4

University of Minnesota Medical Center Fairview - Riverside

Minneapolis, Minnesota, United States, 55454