An interventional study of Vitala in End Colostomy, sponsored by ConvaTec Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by ConvaTec Inc. · Not applicable, Interventional, and Supportive care
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.
ConvaTec Inc. is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Device: Vitala
Vitala™ Continence Control Device
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
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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ConvaTec Inc.