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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01261988 |
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Date of registration:
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15/12/2010 |
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Primary sponsor: |
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Public title:
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Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
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Scientific 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 |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01261988 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Qing Li, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ConvaTec Inc. |
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Key inclusion & exclusion 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 )
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ostomy
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Intervention(s)
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Device: Esteem™ Cut to Fit One Piece Closed End Pouch
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Device: VIPER
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Primary Outcome(s)
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Efficacy: Device Fall-Offs
[Time Frame: 17 hours]
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Efficacy: Device Fall-Offs
[Time Frame: 17 hours]
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Safety: Related Events
[Time Frame: 17 hours]
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Safety: Skin Reactions
[Time Frame: 17 hours]
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Secondary Outcome(s)
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Adhesive
[Time Frame: 1 hour]
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Ease of Removal
[Time Frame: 17 hours]
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Security
[Time Frame: 17 hours]
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Secondary ID(s)
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CC-0512-10-A723
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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