Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™

A Single Center, Feasibility Study Using Healthy Volunteers to Assess the Safety and Adhesive Performance of the VIPER System When Compared to the Esteem™ Cut to Fit One Piece Closed End Pouch

The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Ostomy
• Intervention / Treatment: Device: VIPER; Device: Esteem™ Cut to Fit One Piece Closed End Pouch

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Jobstown, New Jersey, United States, 08041
      • Susan Bell, RN, MSN, CWOCN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female between 18 and 70 years of age (inclusive) at the time of randomization
• Willing and able to provide written informed consent and HIPAA Waiver
• An appropriate candidate for participation with unbroken non-irritated abdominal skin
• Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
• Willing to adhere to the scheduled study visits
• Good manual dexterity and be able to take care of their abdominal area independently
• Be willing and able to record the required study data in a specified format

Exclusion Criteria:

• A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
• Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
• Subjects with any chronic allergies requiring the use of prescription medication
• History of skin disease affecting abdominal area
• Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
• Active case of eczema, dermatitis, psoriasis
• Pregnant or lactating females.
• Subject currently enrolled in another investigational study
• Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Related Events	All adverse events (AE's) related to the use of the device	17 hours
Efficacy: Device Fall-Offs	The number and percentage of subjects with study device fall-off during the study	17 hours
Efficacy: Device Fall-Offs	The total number of study device fall-offs during the course of the study	17 hours
Safety: Skin Reactions		17 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesive	Initial tack of the adhesive (during first hour of wear)	1 hour
Ease of Removal	Ease of removal of the adhesive wafer from the skin	17 hours
Security	Perceived security of the study pouch during wear	17 hours

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Study Director: Qing Li, PhD, ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2010
• Last Update Submitted That Met QC Criteria: December 16, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: CC-0512-10-A723