Vitala 12 Hour Wear Test With Convex Products
The primary objective of this phase II clinical trial is to assess the safety of the Vitala™ device during 12 hours of daily wear with convex products.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase II Vitala 12 Hour Wear Test With Convex Products|
- Safety [ Time Frame: 29 Days ] [ Designated as safety issue: No ]Assess safety during 12 hours of Vitala™ device wear with convex products by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), and stomal vascularity.
- Efficacy: [ Time Frame: 29 Days ] [ Designated as safety issue: No ]
Restoration of Continence (absence of fecal leakage around the device) for 29 days of Vitala™ daily wear according to the following parameters:
- Proportion of subjects with leakage over time.
- Overall weighted leakage rate.
- Proportion of subjects without leakage.
- Self-rating of ability to restore continence.
- Efficacy [ Time Frame: 29 Days ] [ Designated as safety issue: No ]
Vitala™ device will also be evaluated for the following efficacy parameters:
- Security of the device.
- Flange to flange security.
- Device wear time.
- Subject comfort.
- Control of odor.
- Control of noise due to flatus release from the stoma.
- Ease of use of the device during application and removal.
- Subject acceptance of the device.
|Study Start Date:||February 2010|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
For all enrolled Subjects, STAGE 1 (Days 1 - 14 equals Convex Product Wear Period followed by, for those who successfully complete Stage I, weekly increases in wear time of the Vitala™ device beginning with 4 hours of daily wear per week (Days 15 to 21), followed by 8 hours of daily wear time per week (Day 22 to 28), followed by 12 hours of daily wear time (Days 29 to 43).
Vitala™ Continence Control Device
|United States, Arizona|
|Tucson,, Arizona, United States, 85742|
|United States, Florida|
|ET Nursing Services|
|Jacksonville, Florida, United States, 32217|
|United States, Missouri|
|Kansas City, Missouri, United States, 64119|
|St. Joseph,, Missouri, United States, 64506|
|United States, Ohio|
|Reynoldsburg, Ohio, United States, 43068|
|Study Director:||Dheerendra Kommala, MD||ConvaTec Inc.|