Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers

Study Overview
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Brief Summary
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This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.

Detailed Description
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A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the Vitala (TM) Continence Control Device When Worn With SUR FIT Natura® Moldable Technology(TM) Skin Barrier Products Over a 12 Hour Period. This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.

Official Title
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A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the VitalaTM Continence Control Device When Worn With SUR FIT Natura® Moldable TechnologyTM Skin Barrier Products Over a 12 Hour Period

Conditions
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Colostomy

Intervention / Treatment
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* Device: VitalaTM


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. Currently uses a SUR-FIT Natura® Moldable skin barrier or is willing to wear SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange sizes. Enrollment will target as many moldable product users as possible. The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange. Is willing to remove and replace the skin barrier wafer after three days, or more often if desired. 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) 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 L2 or greater according to the SACSTM Rating Scale. Is receiving radiation in the area of the pouching system. Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy. Requires convexity. Requires a pouch belt while wearing Vitala™. Has participated in a clinical study within the past 30 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VitalaTM<br>A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products. | Device: VitalaTM<br>* A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity. | Safety will be assessed by measuring the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity. | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance (Restoration of Continence) | Performance will be assessed through the restoration of continence | 28 Days | 
| Performance (Subjective Assessment) | Performance will be assessed subjectively | 28 Days | 
| Performance (Leakage Rates) | Performance will be assessed through leakage rates | 28 Days |