- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00902252
Multi-National Phase III Vitala™ 12-Hour Wear Test
May 14, 2010 updated by: ConvaTec Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Freiburg, Germany, 79095
- University Hospital Freiburg
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Triwalk, Germany, 23966
- Private Practice
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London, United Kingdom, SW10 9NH
- Chelsea and Westminster Hospital
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London, United Kingdom, E9 6SR
- Homerton University Hospital NHS
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Arizona
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Tuscon, Arizona, United States, 85742
- Private Practice
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Florida
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Jacksonville, Florida, United States, 32246
- ET Nursing Services
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Maryland
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Hagerstown, Maryland, United States, 21740
- Washington County Hospital
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Missouri
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Kansas City, Missouri, United States, 64119
- Restored Images
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St. Joseph, Missouri, United States, 64506
- Image Specialties
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New York
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New York, New York, United States, 10029
- Mt. Sinai Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Reynoldsburg, Ohio, United States, 43068
- Colon and Rectal Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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All subjects will wear their usual pouching system for the first 21 days of the study.
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.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 159 Days
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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.
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159 Days
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Restoration of Continence
Time Frame: 159 days
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Absence of fecal leakage around the device.
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159 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Efficacy
Time Frame: 215 Days
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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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215 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
May 14, 2009
First Submitted That Met QC Criteria
May 14, 2009
First Posted (Estimate)
May 15, 2009
Study Record Updates
Last Update Posted (Estimate)
May 17, 2010
Last Update Submitted That Met QC Criteria
May 14, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- CC-0196-08-A720
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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