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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00902252
Other study ID # CC-0196-08-A720
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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