Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers
- Conditions
- Colostomy
- Interventions
- Device: VitalaTM
- Registration Number
- NCT01207479
- Lead Sponsor
- ConvaTec Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VitalaTM VitalaTM 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Performance (Restoration of Continence) 28 Days Performance will be assessed through the restoration of continence
Performance (Leakage Rates) 28 Days Performance will be assessed through leakage rates
Performance (Subjective Assessment) 28 Days Performance will be assessed subjectively