Feasibility Study of a New Fistula Pouching System

Cutaneous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294450
• Other study ID #: DK140OS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 20, 2006
• Last updated: January 31, 2012
• Start date: February 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2012
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Fistula
• Fistula

Intervention

Device:
• Fistula Pouching System
3 different sizes of fistula pounching system

Locations

Country	Name	City	State
United States	Morton Plant Hospital	Clearwarter	Florida
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	University of Minnesota Medical Center Fairview - Riverside	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nurse's preference to use the test product in the future		Up to 18 days	No