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

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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.