Multi-National Phase III Vitala™ 12-Hour Wear Test
- Conditions
- Colostomy
- Registration Number
- NCT00902252
- Lead Sponsor
- ConvaTec Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety 159 Days 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 159 days Absence of fecal leakage around the device.
- Secondary Outcome Measures
Name Time Method Efficacy 215 Days 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.
Trial Locations
- Locations (11)
Private Practice
🇩🇪Triwalk, Germany
ET Nursing Services
🇺🇸Jacksonville, Florida, United States
Washington County Hospital
🇺🇸Hagerstown, Maryland, United States
Restored Images
🇺🇸Kansas City, Missouri, United States
Image Specialties
🇺🇸St. 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, Germany
Homerton University Hospital NHS
🇬🇧London, United Kingdom
Scroll for more (1 remaining)Private Practice🇩🇪Triwalk, Germany