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

NCT01261988 | Completed Phase 1

• 1 other identifier: CC-0512-10-A723
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ostomy

Outcome Measures

Primary Outcomes (4)

• Safety: Related Events

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

  17 hours

• Efficacy: Device Fall-Offs

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

  17 hours

• Efficacy: Device Fall-Offs

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

  17 hours

• Safety: Skin Reactions

  17 hours

Secondary Outcomes (3)

• Adhesive

  1 hour

• Ease of Removal

  17 hours

• Security

  17 hours

Interventions

VIPER DEVICE

Comparison of ostomy systems

Esteem™ Cut to Fit One Piece Closed End Pouch DEVICE

Comparison of ostomy systems

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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 )

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Susan Bell, RN, MSN, CWOCN

Jobstown, New Jersey, 08041, United States

Location

Study Officials

• Qing Li, PhD

  ConvaTec Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 20, 2010

Record last verified: 2010-12

Locations

US (1)