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 (Responsible Party):
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01207479
First received: September 21, 2010
Last updated: July 29, 2013
Last verified: July 2013
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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 ]

Enrollment: 28
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: July 29, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014