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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ostomy

Intervention / Treatment
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* Device: VIPER
* Device: Esteem™ Cut to Fit One Piece Closed End Pouch


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VIPER|Comparison of ostomy systems|
|Device: Esteem™ Cut to Fit One Piece Closed End Pouch|Comparison of ostomy systems|

What is the study measuring?
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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 |