Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers

NCT01207479 | Completed

• 1 other identifier: CC-0196-09-A725
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Performance (Restoration of Continence)

  28 Days

• Performance (Subjective Assessment)

  28 Days

• Performance (Leakage Rates)

  28 Days

Study Arms (1)

VitalaTM

EXPERIMENTAL

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

Interventions

VitalaTM DEVICE

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.

VitalaTM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Officials

• Qing Li, PhD

  ConvaTec Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 7, 2022

Record last verified: 2013-07