Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Completed

Conditions studied: Ventral Hernia

In brief

This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.

Key facts

Study ID

NCT00866814

Run by

C. R. Bard

People needed

119

Starts

2009-03-01

Expected to finish

2011-05-01

Last updated by the study team

2012-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥ 18
• Be able to undergo study procedures
• Have signed an Informed Consent form (ICF)
• Be diagnosed with a ventral hernia requiring an open surgery for repair.

You may not qualify if…

• Patient is participating in another device or drug study.
• Patient exhibits clinical symptoms indicating infected hernia site.
• Patient currently has a clean contaminated or contaminated site.
• Patient has a life expectancy less than 2 years at the time of enrollment.
• Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.

Where it is running

• Sutter Medical Group GNS — Sacramento, California, United States
• Sacred Heart Health System, Inc. — Pensacola, Florida, United States
• RUSH Univeristy Medical Center — Chicago, Illinois, United States
• Associated Surgical Group — Peoria, Illinois, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Gaston Memorial Hospital — Gastonia, North Carolina, United States
• Novant Clinical Research Institute — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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