ColostomyNCT01207479
Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers
A study testing VitalaTM in people with Colostomy, run by ConvaTec Inc..
Trial summary
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- VitalaTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 2010
- Phase
- Interventional
- 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.
- Currently uses a SUR-FIT Natura® Moldable skin barrier or is willing to wear SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange sizes. Enrollment will target as many moldable product users as possible.
- The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange.
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- Is willing to remove and replace the skin barrier wafer after three days, or more often if desired.
- Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
- Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
- 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 "L2" or greater according to the SACSTM Rating Scale.
- Is receiving radiation in the area of the pouching system.
- Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
- Requires convexity.
- Requires a pouch belt while wearing Vitala™.
- Has participated in a clinical study within the past 30 days.
About this study
Official title: A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the VitalaTM Continence Control Device When Worn With SUR FIT Natura® Moldable TechnologyTM Skin Barrier Products Over a 12 Hour Period
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
Read the detailed description
A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the Vitala (TM) Continence Control Device When Worn With SUR FIT Natura® Moldable Technology(TM) Skin Barrier Products Over a 12 Hour Period.
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
- Conditions
- Colostomy
- Being tested
- VitalaTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalaTMDevice
A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products.
| Study group | Role | What they receive |
|---|---|---|
| VitalaTM | Experimental | A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products. Receives: Device: VitalaTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
Safety will be assessed by measuring the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
Measured: 28 Days
Secondary outcomes (3)
Performance (Restoration of Continence)
Performance will be assessed through the restoration of continence
Measured: 28 Days
Performance (Subjective Assessment)
Performance will be assessed subjectively
Measured: 28 Days
Performance (Leakage Rates)
Performance will be assessed through leakage rates
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Li, PhD, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207479
- Sponsor's protocol ID
- CC-0196-09-A725
- Status last verified
- Jul 2013
- First submitted
- 21 Sep 2010
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the VitalaTM Continence Control Device When Worn With SUR FIT Natura® Moldable TechnologyTM Skin Barrier Products Over a 12 Hour Period
- ClinicalTrials.gov ID
- NCT01207479
- Acronym / sponsor ID
- CC-0196-09-A725
- Conditions
- Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Sep 2010 (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.
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
Detailed description
A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the Vitala (TM) Continence Control Device When Worn With SUR FIT Natura® Moldable Technology(TM) Skin Barrier Products Over a 12 Hour Period.
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VitalaTM | Experimental | Device: VitalaTMA 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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.
- Currently uses a SUR-FIT Natura® Moldable skin barrier or is willing to wear SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange sizes. Enrollment will target as many moldable product users as possible.
Key exclusion criteria (7 listed)
- Has known skin sensitivity to any component of the products being tested.
- Has a skin rating of "L2" or greater according to the SACSTM Rating Scale.
- Is receiving radiation in the area of the pouching system.
- Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
- Requires convexity.
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 |
|---|---|---|
| VitalaTMA 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products. | Device | VitalaTM |
Primary outcome
Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
Time frame: 28 Days
Safety will be assessed by measuring the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
3 secondary outcomes
Performance (Restoration of Continence)
Time frame: 28 Days
Performance (Subjective Assessment)
Time frame: 28 Days
Performance (Leakage Rates)
Time frame: 28 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 7 Dec 2022.
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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.
Qing Li, PhD study director
ConvaTec Inc.
Questions about this trial
What is this clinical trial studying?
A study testing VitalaTM in people with Colostomy, run by ConvaTec Inc..
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 10 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity. (time frame: 28 Days). 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 7 Dec 2022.