Feasibility Study of a New Fistula Pouching System

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294450

Enrollment

Registered

2006-02-22

Start date

2006-02-28

Completion date

2007-03-31

Last updated

2012-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Fistula

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.

Interventions

DEVICEFistula Pouching System

3 different sizes of fistula pounching system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Nurse's preference to use the test product in the future	Up to 18 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026