NCT00902252

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2010

Enrollment Period

9 months

First QC Date

May 14, 2009

Last Update Submit

May 14, 2010

Conditions

Colostomy

Outcome Measures

Primary Outcomes (2)

  • Safety

    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.

    159 Days

  • Restoration of Continence

    Absence of fecal leakage around the device.

    159 days

Secondary Outcomes (1)

  • Efficacy

    215 Days

Study Arms (1)

Usual/Natura®/Vitala™

EXPERIMENTAL

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

Device: UsualDevice: Natura®Device: Vitala™

Interventions

UsualDEVICE

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

Usual/Natura®/Vitala™
Natura®DEVICE

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.

Usual/Natura®/Vitala™
Vitala™DEVICE

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).

Usual/Natura®/Vitala™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Private Practice

Tuscon, Arizona, 85742, United States

Location

ET Nursing Services

Jacksonville, Florida, 32246, United States

Location

Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Restored Images

Kansas City, Missouri, 64119, United States

Location

Image Specialties

Saint Joseph, Missouri, 64506, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Colon and Rectal Surgery

Reynoldsburg, Ohio, 43068, United States

Location

University Hospital Freiburg

Freiburg im Breisgau, 79095, Germany

Location

Private Practice

Triwalk, 23966, Germany

Location

Homerton University Hospital NHS

London, E9 6SR, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Study Officials

  • Dheerendra Kommala, MD

    ConvaTec Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 15, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 17, 2010

Record last verified: 2010-05

Locations

US(8)DE(2)GB(2)