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

This study has been completed.
Information provided by:
ConvaTec Inc. Identifier:
First received: December 15, 2010
Last updated: December 16, 2010
Last verified: December 2010
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.

Condition Intervention Phase
Device: VIPER
Device: Esteem™ Cut to Fit One Piece Closed End Pouch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Safety: Related Events [ Time Frame: 17 hours ]
    All adverse events (AE's) related to the use of the device

  • Efficacy: Device Fall-Offs [ Time Frame: 17 hours ]
    The number and percentage of subjects with study device fall-off during the study

  • Efficacy: Device Fall-Offs [ Time Frame: 17 hours ]
    The total number of study device fall-offs during the course of the study

  • Safety: Skin Reactions [ Time Frame: 17 hours ]

Secondary Outcome Measures:
  • Adhesive [ Time Frame: 1 hour ]
    Initial tack of the adhesive (during first hour of wear)

  • Ease of Removal [ Time Frame: 17 hours ]
    Ease of removal of the adhesive wafer from the skin

  • Security [ Time Frame: 17 hours ]
    Perceived security of the study pouch during wear

Estimated Enrollment: 10
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: VIPER
    Comparison of ostomy systems
    Device: Esteem™ Cut to Fit One Piece Closed End Pouch
    Comparison of ostomy systems

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01261988

United States, New Jersey
Susan Bell, RN, MSN, CWOCN
Jobstown, New Jersey, United States, 08041
Sponsors and Collaborators
ConvaTec Inc.
Study Director: Qing Li, PhD ConvaTec Inc.
  More Information

Responsible Party: Qing Li, Assoc Dir Clinical Research, Convatec Inc. Identifier: NCT01261988     History of Changes
Other Study ID Numbers: CC-0512-10-A723
Study First Received: December 15, 2010
Last Updated: December 16, 2010 processed this record on May 25, 2017