Feasibility Study of a New Fistula Pouching System

Coloplast

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cutaneous Fistula

Treatments: Device: Fistula Pouching System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294450

DK140OS

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)