End Colostomy
Conditions
Brief summary
The primary objective of this phase II clinical trial is to assess the safety of the Vitala™ device during 12 hours of daily wear with convex products.
Interventions
DEVICEVitala
Vitala™ Continence Control Device
Sponsors
ConvaTec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 29 Days | 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. |
| 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. | 29 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Efficacy of Vitala™ device will also be evaluated for the following efficacy parameters. | 29 Days | 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. |
Countries
United States
Outcome results
None listed