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

Convatec

Status: Completed

Conditions: Colostomy

Treatments: Device: VitalaTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT01207479

CC-0196-09-A725

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

VitalaTM

Experimental group

Description:

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.

Treatment:

Device: VitalaTM