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

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01261988
First received: December 15, 2010
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Ostomy
U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • Safety: Related Events [ Time Frame: 17 hours ] [ Designated as safety issue: No ]
    All adverse events (AE's) related to the use of the device

  • Efficacy: Device Fall-Offs [ Time Frame: 17 hours ] [ Designated as safety issue: No ]
    The number and percentage of subjects with study device fall-off during the study

  • Efficacy: Device Fall-Offs [ Time Frame: 17 hours ] [ Designated as safety issue: No ]
    The total number of study device fall-offs during the course of the study

  • Safety: Skin Reactions [ Time Frame: 17 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adhesive [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Initial tack of the adhesive (during first hour of wear)

  • Ease of Removal [ Time Frame: 17 hours ] [ Designated as safety issue: No ]
    Ease of removal of the adhesive wafer from the skin

  • Security [ Time Frame: 17 hours ] [ Designated as safety issue: No ]
    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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261988

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

No publications provided

Responsible Party: Qing Li, Assoc Dir Clinical Research, Convatec Inc.
ClinicalTrials.gov Identifier: NCT01261988     History of Changes
Other Study ID Numbers: CC-0512-10-A723
Study First Received: December 15, 2010
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013