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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01207479
Other study ID # CC-0196-09-A725
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date November 2010

Study information

Verified date July 2013
Source ConvaTec Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ConvaTec Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. 28 Days
Secondary Performance (Restoration of Continence) Performance will be assessed through the restoration of continence 28 Days
Secondary Performance (Subjective Assessment) Performance will be assessed subjectively 28 Days
Secondary Performance (Leakage Rates) Performance will be assessed through leakage rates 28 Days
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