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OpenTrials
Completed

NCT Number: NCT01261988

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Susan Bell, RN, MSN, CWOCN

Jobstown, New Jersey, 08041, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

VIPER

Device

Comparison of ostomy systems

Esteem™ Cut to Fit One Piece Closed End Pouch

Device

Comparison of ostomy systems

Primary outcomes

  1. Safety: Related Events

    Time frame: 17 hours

    All adverse events (AE's) related to the use of the device

  2. Efficacy: Device Fall-Offs

    Time frame: 17 hours

    The number and percentage of subjects with study device fall-off during the study

  3. Efficacy: Device Fall-Offs

    Time frame: 17 hours

    The total number of study device fall-offs during the course of the study

  4. Safety: Skin Reactions

    Time frame: 17 hours

Secondary outcomes

  1. Adhesive

    Time frame: 1 hour

    Initial tack of the adhesive (during first hour of wear)

  2. Ease of Removal

    Time frame: 17 hours

    Ease of removal of the adhesive wafer from the skin

  3. Security

    Time frame: 17 hours

    Perceived security of the study pouch during wear

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2010
Registry last updated
Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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