Vitala 12 Hour Wear Test With Convex Products | NCT01138709

NCT01138709

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Convexity/Vitala	Experimental	For all enrolled Subjects, STAGE 1 (Days 1 - 14 equals Convex Product Wear Period followed by, for those who successfully complete Stage I, weekly increases in wear time of the Vitala™ device beginning with 4 hours of daily wear per week (Days 15 to 21), followed by 8 hours of daily wear time per week (Day 22 to 28), followed by 12 hours of daily wear time (Days 29 to 43).	Device: Vitala

Name	Type	Description	Arm Group Labels	Other Names
Vitala	Device	Vitala™ Continence Control Device	Convexity/Vitala

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of safety during 12 hours of Vitala™ device wear with convex products by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), and stomal vascularity.	Assess safety during 12 hours of Vitala™ device wear with convex products by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), and stomal vascularity.	29 Days
Assessment of the Efficacy in the Restoration of Continence (absence of fecal leakage around the device) for 29 days of Vitala™ daily wear according to the following parameters.	Restoration of Continence (absence of fecal leakage around the device) for 29 days of Vitala™ daily wear according to the following parameters: Proportion of subjects with leakage over time. Overall weighted leakage rate. Proportion of subjects without leakage. Self-rating of ability to restore continence.	29 Days

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the Efficacy of Vitala™ device will also be evaluated for the following efficacy parameters.	Vitala™ device will also be evaluated for the following efficacy parameters: Security of the device. Flange to flange security. Device wear time. Subject comfort. Control of odor. Control of noise due to flatus release from the stoma. Ease of use of the device during application and removal. Subject acceptance of the device.

Eligibility Module

Eligibility Criteria

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.
Currently uses a convex skin barrier wafer or uses convex inserts into standard skin barrier wafers or is willing to wear SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® or SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes. Enrollment will target 15 current convex product users and 10 non convex users.
The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Durahesive® Skin Barrier with CONVEX-IT® in 45mm or 57mm flange size with a stoma opening size from 13mm up to 50mm or the SUR-FIT Natura® Disposable Convex Inserts in 45mm or 57mm flange sizes.
Is willing to remove and replace the skin barrier wafer after three days, more often if desired, during Stage 2.
Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
Is willing to participate in the trial for a total of 43 days.
Is willing to meet with the investigator for a total of 5 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.
Has peristomal ulcerations, peristomal pressure necrosis, parastomal hernia, Caput Medusa or mucocutaneous separation.
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 a moldable skin barrier.
Has participated in a clinical study within the past 30 days.

Facility	Status	City	State	ZIP	Country	Contacts
Non-Institutional Investigator		Tucson	Arizona	85742	United States
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