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
  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:


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
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 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 October 21, 2014