Colostomy
Conditions
Brief summary
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
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.
Interventions
DEVICEVitalaTM
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.
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 28 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance (Restoration of Continence) | 28 Days | Performance will be assessed through the restoration of continence |
| Performance (Subjective Assessment) | 28 Days | Performance will be assessed subjectively |
| Performance (Leakage Rates) | 28 Days | Performance will be assessed through leakage rates |
Outcome results
None listed