ColostomyPhase 3NCT00902252
Multi-National Phase III Vitala™ 12-Hour Wear Test
A Phase 3 study testing Usual, Natura® and Vitala™ in people with Colostomy, run by ConvaTec Inc. at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- Usual, Natura® and Vitala™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Apr 2009to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States8 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Washington County Hospital
Hagerstown, Maryland, 21740
ET Nursing Services
Jacksonville, Florida, 32246
Restored Images
Kansas City, Missouri, 64119
Mt. Sinai Hospital
New York, New York, 10029
Colon and Rectal Surgery
Reynoldsburg, Ohio, 43068
Image Specialties
Saint Joseph, Missouri, 64506
Private Practice
Tuscon, Arizona, 85742
Germany2 sites
University Hospital Freiburg
Freiburg im Breisgau, 79095
Private Practice
Triwalk, 23966
United Kingdom2 sites
Homerton University Hospital NHS
London, E9 6SR
Chelsea and Westminster Hospital
London, SW10 9NH
About this study
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
- Being tested
- Usual, Natura®, Vitala™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UsualDevice
All subjects will wear their usual pouching system for the first 21 days of the study.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Usual; Device: Natura®; Device: Vitala™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 159 Days
Restoration of Continence
Absence of fecal leakage around the device.
Measured: 159 days
Secondary outcomes (1)
Efficacy
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.
Measured: 215 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dheerendra Kommala, MD, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902252
- Sponsor's protocol ID
- CC-0196-08-A720
- Status last verified
- May 2010
- First submitted
- 14 May 2009
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-National Phase III Vitala™ 12-Hour Wear Test
- ClinicalTrials.gov ID
- NCT00902252
- Acronym / sponsor ID
- CC-0196-08-A720
- Conditions
- Colostomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual/Natura®/Vitala™ | Experimental | Device: Usual, Device: Natura®, Device: Vitala™All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UsualAll subjects will wear their usual pouching system for the first 21 days of the study. | Device | Usual/Natura®/Vitala™ |
| 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 | Usual/Natura®/Vitala™ |
| 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). | Device | Usual/Natura®/Vitala™ |
Primary outcome
Safety
Time frame: 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
Time frame: 159 days
Absence of fecal leakage around the device.
1 secondary outcome
Efficacy
Time frame: 215 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheerendra Kommala, MD study director
ConvaTec Inc.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Usual, Natura® and Vitala™ in people with Colostomy, run by ConvaTec Inc. at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 159 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2010.