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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
27
Vitala™ Continence Control Device
Non-Institutional Investigator
Tucson, Arizona, United States
ET Nursing Services
Jacksonville, Florida, United States
Restored Images
Kansas City, Missouri, United States
Image Specialties
Saint Joseph, Missouri, United States
Assessment of 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.
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.
Time frame: 29 Days
Assessment of the Efficacy in the Restoration of Continence (absence of fecal leakage around the device) for 29 days of Vitala™ daily wear according to the following parameters.
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.
Time frame: 29 Days
Assessment of the Efficacy of Vitala™ device will also be evaluated for the following efficacy parameters.
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.
Time frame: 29 Days
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Non-Institutional Investigator
Reynoldsburg, Ohio, United States