Vitala 12 Hour Wear Test With Convex Pr… | Clinical Trial

Key information

Conditions

End Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Non-Institutional Investigator, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitala

Device

Vitala™ Continence Control Device

Primary outcomes

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.

Time frame: 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.

Time frame: 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 outcomes

Assessment of the Efficacy of Vitala™ device will also be evaluated for the following efficacy parameters.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

Phase II Vitala 12 Hour Wear Test With Convex Products

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 7, 2010
Registry last updated: Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.