Feasibility Study of a New Fistula Pouching System

NCT ID: NCT00294450

Last Updated: 2012-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fistula Pouching System

3 different sizes of fistula pounching system

Intervention Type DEVICE

Other Intervention Names

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Fistula and Wound Management System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thais Benjamin N. Christensen, M.Sc. (BME)

Role: STUDY_CHAIR

Coloplast A/S

Locations

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St. Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Morton Plant Hospital

Clearwarter, Florida, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

University of Minnesota Medical Center Fairview - Riverside

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Presbyterian Hospital of Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DK140OS

Identifier Type: -

Identifier Source: org_study_id

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