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CompletedNCT00294450Updated Feb 1, 2012

Feasibility Study of a New Fistula Pouching System

A Phase 2/3 interventional study of Fistula Pouching System in Cutaneous Fistula, sponsored by Coloplast A/S. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-01.

Sponsored by Coloplast A/S · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 the stomach or in a wound on the skin of the stomach.

02

Conditions studied

  • Cutaneous Fistula

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03

In context

Fistula

731 studies on the registry are indexed under Fistula; 103 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 484 interventional studies indexed under Fistula.

Browse Fistula studies →

Lead sponsor

Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnant and/or breast-feeding
  • Receiving radiation- or chemotherapy during the investigation period
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Interventions

  • DeviceFistula Pouching System

    3 different sizes of fistula pounching system

    Also known as: Fistula and Wound Management System

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 18 days

07

Study locations

7 sites
  • St. Francis Hospital and Medical Center
    Hartford, Connecticut 06105, United States
  • Morton Plant Hospital
    Clearwarter, Florida 33756, United States
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
  • University of Minnesota Medical Center Fairview - Riverside
    Minneapolis, Minnesota 55454, United States
  • University of Minnesota Medical Center Fairview
    Minneapolis, Minnesota 55455, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Presbyterian Hospital of Dallas
    Dallas, Texas 75231, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00294450
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Feb 22, 2006
Start date
Feb 2006
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Feb 1, 2012

Study contacts

Thais Benjamin N. Christensen, M.Sc. (BME)
study chair · Coloplast A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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