NCT00294450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

1.1 years

First QC Date

February 20, 2006

Last Update Submit

January 31, 2012

Conditions

Cutaneous Fistula

Outcome Measures

Primary Outcomes (1)

  • Nurse's preference to use the test product in the future

    Up to 18 days

Interventions

Fistula Pouching SystemDEVICE

3 different sizes of fistula pounching system

Also known as: Fistula and Wound Management System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Morton Plant Hospital

Clearwarter, Florida, 33756, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

University of Minnesota Medical Center Fairview - Riverside

Minneapolis, Minnesota, 55454, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Cutaneous Fistula

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

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

    Coloplast A/S

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2006

First Posted

February 22, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

US(7)