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

Convatec

Status and phase

Completed

Phase 3

Conditions

Colostomy

Treatments

Device: Usual

Device: Vitala™

Device: Natura®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00902252

CC-0196-08-A720

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.