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.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00902252
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT00902252
United States (8)
Tuscon, Arizona, United States, 85742
ET Nursing Services
Jacksonville, Florida, United States, 32246
Washington County Hospital
Hagerstown, Maryland, United States, 21740
Kansas City, Missouri, United States, 64119
St. Joseph, Missouri, United States, 64506
Mt. Sinai Hospital
New York, New York, United States, 10029
Cleveland, Ohio, United States, 44195
Colon and Rectal Surgery
Reynoldsburg, Ohio, United States, 43068
University Hospital Freiburg
Freiburg, Germany, 79095
Triwalk, Germany, 23966
United Kingdom (2)
Homerton University Hospital NHS
London, United Kingdom, E9 6SR
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
View full eligibility
Tris trial is registered with FDA with number: NCT00902252. The sponsor of the trial is ConvaTec Inc. and it is looking for 78 volunteers for the current phase.
Official trial title: Multi-National Phase III Vitala™ 12-Hour Wear Test
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