NCT01138709|Completed
Vitala 12 Hour Wear Test With Convex Products
Phase II Vitala 12 Hour Wear Test With Convex Products
Loading search results
Phase II Vitala 12 Hour Wear Test With Convex Products
Sponsor study identifier
interventional
27
1 country
5
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 2010
Actual (reported)April 2010
Actual (reported)June 4, 2010
Actual (reported)June 7, 2010
Actual (reported)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.
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.
29 Days
Assessment of the Efficacy of Vitala™ device will also be evaluated for the following efficacy parameters.
29 Days
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).
Vitala™ Continence Control Device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Non-Institutional Investigator
Tucson, Arizona, 85742, United States
ET Nursing Services
Jacksonville, Florida, 32217, United States
Restored Images
Kansas City, Missouri, 64119, United States
Image Specialties
Saint Joseph, Missouri, 64506, United States
Non-Institutional Investigator
Reynoldsburg, Ohio, 43068, United States
Dheerendra Kommala, MD
ConvaTec Inc.
27 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2010
First Posted
June 7, 2010
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)Last Updated
December 7, 2022
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: