Multi-National Phase III Vitala™ 12-Hour Wear Test

Phase 3

Completed

• Conditions: Colostomy
• Interventions: Device: Usual; Device: Natura®; Device: Vitala™

• Registration Number: NCT00902252
• Lead Sponsor: ConvaTec Inc.

Brief Summary

The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control Device is both safe and effective when worn up to 12 hours per day.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-14
• Last Update Posted: 2010-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.
• Is able to wear a Natura® skin barrier wafer flange in size 45mm or 57 mm.
• Is willing to remove and replace the skin barrier wafer after three days, more often if desired.
• Has a stoma that protrudes no more than 2 cm at rest.
• Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
• Is willing to participate in the trial for a total of 215 days. (approximately 7 months)
• Is willing to meet with the investigator for a total of 12 scheduled visits plus additional visits as deemed necessary by the investigator.
• Has the ability to do complete self-care.

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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.
• 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 convexity or a moldable skin barrier.
• Has participated in a clinical study within the past 90 days.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual/Natura®/Vitala™	Usual	All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
Usual/Natura®/Vitala™	Natura®	All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
Usual/Natura®/Vitala™	Vitala™	All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.

Primary Outcome Measures

Name	Time	Method
Safety	159 Days	Will be assessed by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), microbiology profile and stomal vascularity.
Restoration of Continence	159 days	Absence of fecal leakage around the device.

Secondary Outcome Measures

Name	Time	Method
Efficacy	215 Days	Will be assessed by the following: measurement of health economic outcomes, resource use, security, wear time, comfort, control of odor, control of noise, ease of use during application and removal, subject acceptance of the device.

Trial Locations

Locations (11)

Private Practice; 🇩🇪 Triwalk, Germany

ET Nursing Services; 🇺🇸 Jacksonville, Florida, United States

Washington County Hospital; 🇺🇸 Hagerstown, Maryland, United States

Colon and Rectal Surgery; 🇺🇸 Reynoldsburg, Ohio, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

Restored Images; 🇺🇸 Kansas City, Missouri, United States

Image Specialties; 🇺🇸 St. Joseph, Missouri, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Homerton University Hospital NHS; 🇬🇧 London, United Kingdom

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom