Multi-National Phase III Vitala™ 12-Hour Wear Test
This study has been completed.
Information provided by:
First received: May 14, 2009
Last updated: May 14, 2010
Last verified: May 2010
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-National Phase III Vitala™ 12-Hour Wear Test|
Further study details as provided by ConvaTec Inc.:
Primary Outcome Measures:
- Safety [ Time Frame: 159 Days ] [ Designated as safety issue: No ]Will be assessed by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), microbiology profile and stomal vascularity.
- Restoration of Continence [ Time Frame: 159 days ] [ Designated as safety issue: No ]Absence of fecal leakage around the device.
Secondary Outcome Measures:
- Efficacy [ Time Frame: 215 Days ] [ Designated as safety issue: No ]Will be assessed by the following: measurement of health economic outcomes, resource use, security, wear time, comfort, control of odor, control of noise, ease of use during application and removal, subject acceptance of the device.
|Study Start Date:||April 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902252
|United States, Arizona|
|Tuscon, Arizona, United States, 85742|
|United States, Florida|
|ET Nursing Services|
|Jacksonville, Florida, United States, 32246|
|United States, Maryland|
|Washington County Hospital|
|Hagerstown, Maryland, United States, 21740|
|United States, Missouri|
|Kansas City, Missouri, United States, 64119|
|St. Joseph, Missouri, United States, 64506|
|United States, New York|
|Mt. Sinai Hospital|
|New York, New York, United States, 10029|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Colon and Rectal Surgery|
|Reynoldsburg, Ohio, United States, 43068|
|University Hospital Freiburg|
|Freiburg, Germany, 79095|
|Triwalk, Germany, 23966|
|Chelsea and Westminster Hospital|
|London, United Kingdom, SW10 9NH|
|Homerton University Hospital NHS|
|London, United Kingdom, E9 6SR|
Sponsors and Collaborators
|Study Director:||Dheerendra Kommala, MD||ConvaTec Inc.|