Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
NCT ID: NCT00866814
Last Updated: 2012-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
119 participants
OBSERVATIONAL
2009-03-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ventrio Group
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
Bard Ventrio Hernia Patch
The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Interventions
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Bard Ventrio Hernia Patch
The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Eligibility Criteria
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Inclusion Criteria
2. Be able to undergo study procedures
3. Have signed an Informed Consent form (ICF)
4. Be diagnosed with a ventral hernia requiring an open surgery for repair.
Exclusion Criteria
2. Patient exhibits clinical symptoms indicating infected hernia site.
3. Patient currently has a clean contaminated or contaminated site.
4. Patient has a life expectancy less than 2 years at the time of enrollment.
5. 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.
18 Years
ALL
No
Sponsors
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FGK Clinical Research GmbH
INDUSTRY
C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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David Iannitti, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Locations
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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
Countries
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Other Identifiers
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DVL-HE004
Identifier Type: -
Identifier Source: org_study_id