Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
Completed · Phase 1
Conditions studied: Ostomy
In brief
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.
Key facts
- Study ID
- NCT01261988
- Run by
- ConvaTec Inc.
- People needed
- 10
- Starts
- 2010-12-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2010-12-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 )
Where it is running
- Susan Bell, RN, MSN, CWOCN — Jobstown, New Jersey, United States
Full record on ClinicalTrials.gov
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