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A Multi-Center Feasibility Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01207479
First received: September 21, 2010
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Colostomy
 Device: VitalaTM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Performance (Restoration of Continence) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Performance (Subjective Assessment) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Performance (Leakage Rates) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207479

Sponsors and Collaborators
ConvaTec Inc.
Investigators
Study Director: Qing Li, PhD ConvaTec Inc.
  More Information

No publications provided

Responsible Party: Qing Li, Assoc Dir Clinical Research, Convatec Inc.
ClinicalTrials.gov Identifier: NCT01207479     History of Changes
Other Study ID Numbers: CC-0196-09-A725
Study First Received: September 21, 2010
Last Updated: January 21, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013