Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
NCT ID: NCT01261988
Last Updated: 2010-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2010-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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VIPER
Comparison of ostomy systems
Esteem™ Cut to Fit One Piece Closed End Pouch
Comparison of ostomy systems
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 )
18 Years
70 Years
ALL
Yes
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Convatec Inc.
Principal Investigators
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Qing Li, PhD
Role: STUDY_DIRECTOR
ConvaTec Inc.
Locations
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Susan Bell, RN, MSN, CWOCN
Jobstown, New Jersey, United States
Countries
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Other Identifiers
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CC-0512-10-A723
Identifier Type: -
Identifier Source: org_study_id