Multi-National Phase III Vitala™ 12-Hour Wear Test

Completed · Phase 3

Conditions studied: Colostomy

In brief

The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control Device is both safe and effective when worn up to 12 hours per day.

Key facts

Study ID

NCT00902252

Run by

ConvaTec Inc.

People needed

78

Starts

2009-04-01

Expected to finish

2010-01-01

Last updated by the study team

2010-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is of legal consenting age.
• Is able to read, write, and understand the study, the required procedures, and the study related documentation.
• Has signed the informed consent.
• Has an end colostomy of at least 12 weeks duration with formed or semi- formed effluent.
• Is able to wear a Natura® skin barrier wafer flange in size 45mm or 57 mm.
• Is willing to remove and replace the skin barrier wafer after three days, more often if desired.
• Has a stoma that protrudes no more than 2 cm at rest.
• Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
• Is willing to participate in the trial for a total of 215 days. (approximately 7 months)
• Is willing to meet with the investigator for a total of 12 scheduled visits plus additional visits as deemed necessary by the investigator.
• Has the ability to do complete self-care.

You may not qualify if…

• Has known skin sensitivity to any component of the products being tested.
• Has a skin rating of "2" or greater according to the Skin Rating Scale.
• Is receiving radiation in the area of the pouching system.
• Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
• Requires a pouch belt while wearing Vitala
• Requires convexity or a moldable skin barrier.
• Has participated in a clinical study within the past 90 days.

Where it is running

• Private Practice — Tuscon, Arizona, United States
• ET Nursing Services — Jacksonville, Florida, United States
• Washington County Hospital — Hagerstown, Maryland, United States
• Restored Images — Kansas City, Missouri, United States
• Image Specialties — Saint Joseph, Missouri, United States
• Mt. Sinai Hospital — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Colon and Rectal Surgery — Reynoldsburg, Ohio, United States
• University Hospital Freiburg — Freiburg im Breisgau, Germany
• Private Practice — Triwalk, Germany
• Homerton University Hospital NHS — London, United Kingdom
• Chelsea and Westminster Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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