Multi-National Phase III Vitala™ 12-Hour Wear Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902252
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : May 17, 2010
Information provided by:
ConvaTec Inc.

May 14, 2009
May 15, 2009
May 17, 2010
April 2009
January 2010   (Final data collection date for primary outcome measure)
  • Safety [ Time Frame: 159 Days ]
    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.
  • Restoration of Continence [ Time Frame: 159 days ]
    Absence of fecal leakage around the device.
Not Provided
Complete list of historical versions of study NCT00902252 on Archive Site
Efficacy [ Time Frame: 215 Days ]
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.
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Multi-National Phase III Vitala™ 12-Hour Wear Test
Multi-National Phase III Vitala™ 12-Hour Wear Test
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.
Not Provided
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Device: Usual
    All subjects will wear their usual pouching system for the first 21 days of the study.
  • Device: Natura®
    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.
  • Device: Vitala™
    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).
Experimental: Usual/Natura®/Vitala™
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™
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is of legal consenting age.
  • Is able to read, write, and understand the study, the required procedures, and the study related documentation.
  • Has signed the informed consent.
  • Has an end colostomy of at least 12 weeks duration with formed or semi- formed effluent.
  • Is able to wear a Natura® skin barrier wafer flange in size 45mm or 57 mm.
  • Is willing to remove and replace the skin barrier wafer after three days, more often if desired.
  • Has a stoma that protrudes no more than 2 cm at rest.
  • Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
  • Is willing to participate in the trial for a total of 215 days. (approximately 7 months)
  • Is willing to meet with the investigator for a total of 12 scheduled visits plus additional visits as deemed necessary by the investigator.
  • Has the ability to do complete self-care.

Exclusion Criteria:

  • Has known skin sensitivity to any component of the products being tested.
  • Has a skin rating of "2" or greater according to the Skin Rating Scale.
  • Is receiving radiation in the area of the pouching system.
  • Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
  • Requires a pouch belt while wearing Vitala
  • Requires convexity or a moldable skin barrier.
  • Has participated in a clinical study within the past 90 days.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom,   United States
Not Provided
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Dheerendra Kommala, MD / VP of Clinical Development, Convatec
ConvaTec Inc.
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Study Director: Dheerendra Kommala, MD ConvaTec Inc.
ConvaTec Inc.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP