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

NCT00902252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2010-05-17

No results posted yet for this study

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.

Conditions

  • Colostomy

Interventions

DEVICE

Usual

All subjects will wear their usual pouching system for the first 21 days of the study.

DEVICE

Natura®

All subjects will wear the Natura® Flexible Skin Barrier with Flange (Stomahesive® or Durahesive®) in the US and Natura® Stomahesive® Flexible Skin Barrier with Flange in Europe for 14 days.

DEVICE

Vitala™

After the successful completion of Stages 1 and 2, subjects will enter the "ramp up" schedule to allow the subject to adjust to the device. This consists of weekly increases in wear time of the Vitala™ device beginning with 4 hours of daily wear per week (Days 36 to 42), followed by 6 hours of daily wear time per week (Day 43 to 49), followed by 8 hours of daily wear time (Days 50 to 56) and progressing to 12 hours of daily wear per week (Day 57 to 215).

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Dheerendra Kommala, MD · ConvaTec Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00902252 on ClinicalTrials.gov