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

Study Overview
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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.

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

Conditions
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Colostomy

Intervention / Treatment
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* Device: Usual
* Device: Natura®
* Device: Vitala™


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual/Natura®/Vitala™<br>All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days. | Device: Usual<br>* All subjects will wear their usual pouching system for the first 21 days of the study.<br>Device: Natura®<br>* 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.<br>Device: Vitala™<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Restoration of Continence | Absence of fecal leakage around the device. | 159 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |