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
  Purpose

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.


Condition Intervention Phase
Colostomy
Device: Usual
Device: Natura®
Device: Vitala™
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-National Phase III Vitala™ 12-Hour Wear Test

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 78
Study Start Date: April 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902252

Locations
United States, Arizona
Private Practice
Tuscon, Arizona, United States, 85742
United States, Florida
ET Nursing Services
Jacksonville, Florida, United States, 32246
United States, Maryland
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Missouri
Restored Images
Kansas City, Missouri, United States, 64119
Image Specialties
St. Joseph, Missouri, United States, 64506
United States, New York
Mt. Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Colon and Rectal Surgery
Reynoldsburg, Ohio, United States, 43068
Germany
University Hospital Freiburg
Freiburg, Germany, 79095
Private Practice
Triwalk, Germany, 23966
United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Homerton University Hospital NHS
London, United Kingdom, E9 6SR
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Study Director: Dheerendra Kommala, MD ConvaTec Inc.
  More Information

No publications provided

Responsible Party: Dheerendra Kommala, MD / VP of Clinical Development, Convatec
ClinicalTrials.gov Identifier: NCT00902252     History of Changes
Other Study ID Numbers: CC-0196-08-A720
Study First Received: May 14, 2009
Last Updated: May 14, 2010
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Dutch Health Care Inspectorate

ClinicalTrials.gov processed this record on October 30, 2014