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

Sponsor
ConvaTec Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00902252
Collaborator
(none)
78
Enrollment
12
Locations
1
Arm
9
Duration (Months)
6.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Usual
  • Device: Natura®
  • Device: Vitala™
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-National Phase III Vitala™ 12-Hour Wear Test
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Usual/Natura®/Vitala™

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

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).

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Restoration of Continence [159 days]

    Absence of fecal leakage around the device.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Practice Tuscon Arizona United States 85742
2 ET Nursing Services Jacksonville Florida United States 32246
3 Washington County Hospital Hagerstown Maryland United States 21740
4 Restored Images Kansas City Missouri United States 64119
5 Image Specialties St. Joseph Missouri United States 64506
6 Mt. Sinai Hospital New York New York United States 10029
7 Cleveland Clinic Cleveland Ohio United States 44195
8 Colon and Rectal Surgery Reynoldsburg Ohio United States 43068
9 University Hospital Freiburg Freiburg Germany 79095
10 Private Practice Triwalk Germany 23966
11 Homerton University Hospital NHS London United Kingdom E9 6SR
12 Chelsea and Westminster Hospital London United Kingdom SW10 9NH

Sponsors and Collaborators

  • ConvaTec Inc.

Investigators

  • Study Director: Dheerendra Kommala, MD, ConvaTec Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00902252
Other Study ID Numbers:
  • CC-0196-08-A720
First Posted:
May 15, 2009
Last Update Posted:
May 17, 2010
Last Verified:
May 1, 2010

Study Results

No Results Posted as of May 17, 2010