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OpenTrials
Completed

NCT Number: NCT00294450

Feasibility Study of a New Fistula Pouching System

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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Key information

Conditions

Cutaneous Fistula Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

St. Francis Hospital and Medical Center, Hartford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fistula Pouching System

Device

3 different sizes of fistula pounching system

Other names: Fistula and Wound Management System

Primary outcomes

  1. Nurse's preference to use the test product in the future

    Time frame: Up to 18 days

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Pouching of Fistula - a Non-comparative, Multi-center Investigation

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 22, 2006
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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