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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colostomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual/Natura®/Vitala™

All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.

Group Type EXPERIMENTAL

Usual

Intervention Type DEVICE

All subjects will wear their usual pouching system for the first 21 days of the study.

Natura®

Intervention Type DEVICE

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™

Intervention Type DEVICE

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).

Interventions

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Usual

All subjects will wear their usual pouching system for the first 21 days of the study.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No