A Phase 3 interventional study of Usual and Natura® in Colostomy, sponsored by ConvaTec Inc.. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-17.
Sponsored by ConvaTec Inc. · Phase 3, Interventional, and Treatment
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.
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:
All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
Device: Usual · Device: Natura® · Device: Vitala™
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).
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
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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ConvaTec Inc.