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

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT00902252
First received: May 14, 2009
Last updated: May 14, 2010
Last verified: May 2010

May 14, 2009
May 14, 2010
April 2009
January 2010   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 159 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Absence of fecal leakage around the device.
Not Provided
Complete list of historical versions of study NCT00902252 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: 215 Days ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colostomy
  • 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.
Interventions:
  • Device: Usual
  • Device: Natura®
  • Device: Vitala™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom
 
NCT00902252
CC-0196-08-A720
No
Dheerendra Kommala, MD / VP of Clinical Development, Convatec
ConvaTec Inc.
Not Provided
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