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Completed

NCT Number: NCT01207479

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

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.

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Key information

Conditions

Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

VitalaTM

Device

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.

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.

    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.

Secondary outcomes

  1. Performance (Restoration of Continence)

    Time frame: 28 Days

    Performance will be assessed through the restoration of continence

  2. Performance (Subjective Assessment)

    Time frame: 28 Days

    Performance will be assessed subjectively

  3. Performance (Leakage Rates)

    Time frame: 28 Days

    Performance will be assessed through leakage rates

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2010
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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