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

Sponsor

ConvaTec Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01207479

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colostomy	Device: VitalaTM	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Safety [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 Outcome Measures

Performance (Restoration of Continence) [28 Days]
Performance (Subjective Assessment) [28 Days]
Performance (Leakage Rates) [28 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

ConvaTec Inc.

Investigators

Study Director: Qing Li, PhD, ConvaTec Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ConvaTec Inc.

ClinicalTrials.gov Identifier:

NCT01207479

Other Study ID Numbers:

CC-0196-09-A725

First Posted:

Sep 23, 2010

Last Update Posted:

Jul 30, 2013

Last Verified:

Jul 1, 2013

Study Results

No Results Posted as of Jul 30, 2013