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

Phase 1

Completed

• Conditions: Ostomy

• Registration Number: NCT01261988
• Lead Sponsor: ConvaTec Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Last Update Submitted: 2010-12-16
• Study First Posted: 2010-12-17
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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 )

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety: Related Events	17 hours	All adverse events (AE's) related to the use of the device
Efficacy: Device Fall-Offs	17 hours	The total number of study device fall-offs during the course of the study
Safety: Skin Reactions	17 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Susan Bell, RN, MSN, CWOCN; 🇺🇸 Jobstown, New Jersey, United States