Status:
COMPLETED
Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers
Lead Sponsor:
ConvaTec Inc.
Conditions:
Colostomy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 Prod...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01207479
Start Date
September 1 2010
End Date
November 1 2010
Last Update
December 7 2022
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