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

Ostomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261988
• Other study ID #: CC-0512-10-A723
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2010
• Last updated: December 16, 2010
• Start date: December 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 )

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ostomy

Intervention

Device:
• VIPER
Comparison of ostomy systems
• Esteem™ Cut to Fit One Piece Closed End Pouch
Comparison of ostomy systems

Locations

Country	Name	City	State
United States	Susan Bell, RN, MSN, CWOCN	Jobstown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Related Events	All adverse events (AE's) related to the use of the device	17 hours	No
Primary	Efficacy: Device Fall-Offs	The number and percentage of subjects with study device fall-off during the study	17 hours	No
Primary	Efficacy: Device Fall-Offs	The total number of study device fall-offs during the course of the study	17 hours	No
Primary	Safety: Skin Reactions		17 hours	No
Secondary	Adhesive	Initial tack of the adhesive (during first hour of wear)	1 hour	No
Secondary	Ease of Removal	Ease of removal of the adhesive wafer from the skin	17 hours	No
Secondary	Security	Perceived security of the study pouch during wear	17 hours	No