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

September 21, 2010
July 29, 2013
September 2010
November 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01207479 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Multi-Center Feasibility Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Colostomy
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.
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.
Intervention: Device: VitalaTM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01207479
CC-0196-09-A725
No
ConvaTec Inc.
ConvaTec Inc.
Not Provided
Study Director: Qing Li, PhD ConvaTec Inc.
ConvaTec Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP