Clinical trial NCT00902252: Multi-National Phase III Vitala™ 12-Hour Wear Test
Official title: Multi-National Phase III Vitala™ 12-Hour Wear Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colostomy
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Safety
timeFrame: 159 Days
measure: Restoration of Continence
timeFrame: 159 days
Secondary outcomes:
measure: Efficacy
timeFrame: 215 Days
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Private Practice
state: Arizona
city: Jacksonville
country: United States
facility: ET Nursing Services
state: Florida
city: Hagerstown
country: United States
facility: Washington County Hospital
state: Maryland
city: Kansas City
country: United States
facility: Restored Images
state: Missouri
city: St. Joseph
country: United States
facility: Image Specialties
state: Missouri
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Reynoldsburg
country: United States
facility: Colon and Rectal Surgery
state: Ohio
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Triwalk
country: Germany
facility: Private Practice
city: London
country: United Kingdom
facility: Homerton University Hospital NHS
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: ConvaTec Inc.
name: Dheerendra Kommala, MD
role: STUDY_DIRECTOR
References: