Multi-National Phase III Vitala™ 12-Hour Wear Test

Colostomy Clinical Trial

Official title:

Multi-National Phase III Vitala™ 12-Hour Wear Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902252
• Other study ID #: CC-0196-08-A720
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2009
• Last updated: May 14, 2010
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2010
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colostomy

Intervention

Device:
• Usual
All subjects will wear their usual pouching system for the first 21 days of the study.
• Natura®
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.
• Vitala™
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).

Locations

Country	Name	City	State
Germany	University Hospital Freiburg	Freiburg
Germany	Private Practice	Triwalk
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Homerton University Hospital NHS	London
United States	Cleveland Clinic	Cleveland	Ohio
United States	Washington County Hospital	Hagerstown	Maryland
United States	ET Nursing Services	Jacksonville	Florida
United States	Restored Images	Kansas City	Missouri
United States	Mt. Sinai Hospital	New York	New York
United States	Colon and Rectal Surgery	Reynoldsburg	Ohio
United States	Image Specialties	St. Joseph	Missouri
United States	Private Practice	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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.	159 Days
Primary	Restoration of Continence	Absence of fecal leakage around the device.	159 days
Secondary	Efficacy	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.	215 Days