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Vitala 12 Hour Wear Test With Convex Products

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01138709
First received: June 4, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
End Colostomy
 Device: Vitala
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase II Vitala 12 Hour Wear Test With Convex Products

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 29 Days ] [ Designated as safety issue: No ]
    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.

  • Efficacy: [ Time Frame: 29 Days ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 29 Days ] [ Designated as safety issue: No ]

    Vitala™ device will also be evaluated for the following efficacy parameters:

    • Security of the device.
    • Flange to flange security.
    • Device wear time.
    • Subject comfort.
    • Control of odor.
    • Control of noise due to flatus release from the stoma.
    • Ease of use of the device during application and removal.
    • Subject acceptance of the device.


Enrollment: 27
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Convexity/Vitala
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).
 Device: Vitala
Vitala™ Continence Control Device

  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.
  • Currently uses a convex skin barrier wafer or uses convex inserts into standard skin barrier wafers or is willing to wear SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® or SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes. Enrollment will target 15 current convex product users and 10 non convex users.
  • The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® in 45mm or 57mm flange size with a stoma opening size from 13mm up to 50mm or the SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes.
  • Is willing to remove and replace the skin barrier wafer after three days, more often if desired, during Stage 2.
  • Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
  • Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
  • Is willing to participate in the trial for a total of 43 days.
  • Is willing to meet with the investigator for a total of 5 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.
  • Has peristomal ulcerations, peristomal pressure necrosis, parastomal hernia, Caput Medusa or mucocutaneous separation.
  • 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 a moldable skin barrier.
  • Has participated in a clinical study within the past 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138709

Locations
United States, Arizona
Non-Institutional Investigator
Tucson,, Arizona, United States, 85742
United States, Florida
ET Nursing Services
Jacksonville, Florida, United States, 32217
United States, Missouri
Restored Images
Kansas City, Missouri, United States, 64119
Image Specialties
St. Joseph,, Missouri, United States, 64506
United States, Ohio
Non-Institutional Investigator
Reynoldsburg, Ohio, United States, 43068
Sponsors and Collaborators
ConvaTec Inc.
Investigators
Study Director: Dheerendra Kommala, MD ConvaTec Inc.
  More Information

No publications provided

Responsible Party: Dheerendra Kommala,MD; VP clinical Development, Health Economics and Safety and Compliance, ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT01138709     History of Changes
Other Study ID Numbers: CC-0196-09-A721
Study First Received: June 4, 2010
Last Updated: June 4, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013