Status:
COMPLETED
Multi-National Phase III Vitala™ 12-Hour Wear Test
Lead Sponsor:
ConvaTec Inc.
Conditions:
Colostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00902252
Start Date
April 1 2009
End Date
January 1 2010
Last Update
May 17 2010
Active Locations (12)
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1
Private Practice
Tuscon, Arizona, United States, 85742
2
ET Nursing Services
Jacksonville, Florida, United States, 32246
3
Washington County Hospital
Hagerstown, Maryland, United States, 21740
4
Restored Images
Kansas City, Missouri, United States, 64119