ClinicalTrials.gg
Sign In
CompletedNCT01207479Updated Dec 7, 2022

Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers

An interventional study of VitalaTM in Colostomy, sponsored by ConvaTec Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by ConvaTec Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colostomy
03

In context

Lead sponsor

ConvaTec Inc. is the lead sponsor of 46 studies on the registry; 5 are open to participants now.

Browse ConvaTec Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    VitalaTM

    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.

    Device: VitalaTM

Interventions

  • DeviceVitalaTM

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 Days

Secondary outcomes

  1. Performance (Restoration of Continence)

    Performance will be assessed through the restoration of continence

    Time frame: 28 Days

  2. Performance (Subjective Assessment)

    Performance will be assessed subjectively

    Time frame: 28 Days

  3. Performance (Leakage Rates)

    Performance will be assessed through leakage rates

    Time frame: 28 Days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2010, a primary completion of Nov 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2010
First posted
Sep 23, 2010
Start
Sep 2010
Primary completionActual
Nov 2010
CompletionActual
Nov 2010
Last update
Dec 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01207479
Lead sponsor
ConvaTec Inc.
Responsible party
Sponsor
First posted
Sep 23, 2010
Start date
Sep 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Dec 7, 2022

Study contacts

Qing Li, PhD
study director · ConvaTec Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

ConvaTec Inc. →

Start the discussion