Back to resultsFeasibility Study of a New Fistula Pouching System
Primary Purpose
Cutaneous Fistula
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fistula Pouching System
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Fistula
Eligibility Criteria
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
Sites / Locations
- St. Francis Hospital and Medical Center
- Morton Plant Hospital
- Fairview Southdale Hospital
- University of Minnesota Medical Center Fairview - Riverside
- University of Minnesota Medical Center Fairview
- The Cleveland Clinic Foundation
- Presbyterian Hospital of Dallas
Outcomes
Primary Outcome Measures
Nurse's preference to use the test product in the future
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00294450
Brief Title
Feasibility Study of a New Fistula Pouching System
Official Title
Pouching of Fistula - a Non-comparative, Multi-center Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 the stomach or in a wound on the skin of the stomach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Fistula Pouching System
Other Intervention Name(s)
Fistula and Wound Management System
Intervention Description
3 different sizes of fistula pounching system
Primary Outcome Measure Information:
Title
Nurse's preference to use the test product in the future
Time Frame
Up to 18 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Benjamin N. Christensen, M.Sc. (BME)
Organizational Affiliation
Coloplast A/S
Official's Role
Study Chair
Facility Information:
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwarter
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Minnesota Medical Center Fairview - Riverside
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
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Feasibility Study of a New Fistula Pouching System
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