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

Convatec

Status and phase

Completed

Phase 1

Conditions

Ostomy

Treatments

Device: VIPER

Device: Esteem™ Cut to Fit One Piece Closed End Pouch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01261988

CC-0512-10-A723

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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 )