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

NCT ID: NCT01207479

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-11-30

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.

Detailed 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.

Conditions

Colostomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VitalaTM

Intervention Type: 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.

Interventions

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 Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Li, PhD

Role: STUDY_DIRECTOR

ConvaTec Inc.

Other Identifiers

CC-0196-09-A725

Identifier Type: -

Identifier Source: org_study_id