Status:
COMPLETED
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
Lead Sponsor:
C. R. Bard
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Ventral Hernia
Eligibility:
All Genders
18+ years
Brief Summary
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 complication...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00866814
Start Date
March 1 2009
End Date
May 1 2011
Last Update
October 12 2012
Active Locations (7)
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1
Sutter Medical Group GNS
Sacramento, California, United States
2
Sacred Heart Health System, Inc.
Pensacola, Florida, United States, 32504
3
RUSH Univeristy Medical Center
Chicago, Illinois, United States
4
Associated Surgical Group
Peoria, Illinois, United States