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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
All subjects will wear their usual pouching system for the first 21 days of the study.
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.
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).
Private Practice
Tuscon, Arizona, United States
ET Nursing Services
Jacksonville, Florida, United States
Washington County Hospital
Hagerstown, Maryland, United States
Safety
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.
Time frame: 159 Days
Restoration of Continence
Absence of fecal leakage around the device.
Time frame: 159 days
Efficacy
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.
Time frame: 215 Days
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Restored Images
Kansas City, Missouri, United States
Image Specialties
Saint 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 im Breisgau, Germany
Private Practice
Triwalk, Germany
...and 2 more locations