NCT00902252

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colostomy

Interventions

Type	Name	Description
DEVICE	Usual	All subjects will wear their usual pouching system for the first 21 days of the study.
DEVICE	Natura®	All subjects will wear the Natura® Flexible Skin Barrier with Flange (Stomahesive® or Durahesive®) in the US and Natura® Stomahesive® Flexible Skin Barrier with Flange in Europe for 14 days.
DEVICE	Vitala™	After the successful completion of Stages 1 and 2, subjects will enter the "ramp up" schedule to allow the subject to adjust to the device. This consists of weekly increases in wear time of the Vitala™ device beginning with 4 hours of daily wear per week (Days 36 to 42), followed by 6 hours of daily wear time per week (Day 43 to 49), followed by 8 hours of daily wear time (Days 50 to 56) and progressing to 12 hours of daily wear per week (Day 57 to 215).

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-05-15
• Last updated: 2010-05-17

Locations

12 sites across 3 countries: United States, Germany, United Kingdom