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Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

This study has been completed.
Information provided by (Responsible Party):
Cook Identifier:
First received: February 4, 2013
Last updated: June 7, 2016
Last verified: June 2016
The Hybrid Graft study is a post-market observational study to collect data on the performance of the Hybrid Graft when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.

Condition Intervention
Ventral Hernias
Device: Hybrid Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Rate of hernia recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: February 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hybrid Graft Device: Hybrid Graft
Hybrid Graft for ventral hernia repair


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from University of Tennessee, Duke University and Cleveland Clinic

Inclusion Criteria:

  • Primary or recurrent ventral hernia
  • Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result

Exclusion Criteria:

  • Age < 21 (i.e., infants, children)
  • Device intended to be used in an infected wound
  • Known sensitivity to porcine material
  • Pregnant or planning pregnancy in the future
  • Life expectancy of less than 12 months from the date of the index procedure
  • Hernia too large to be covered with a single device with at least 4-5 cm of tissue overlap on all sides
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01784822

United States, North Carolina
Duke University
Durham, North Carolina, United States, 27704
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17036
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37902
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
  More Information

Responsible Party: Cook Identifier: NCT01784822     History of Changes
Other Study ID Numbers: 12-013 
Study First Received: February 4, 2013
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Ventral hernia
Graft repair

Additional relevant MeSH terms:
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal processed this record on October 21, 2016