Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Completed

Conditions studied: Ventral Hernias

In brief

The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.

Key facts

Study ID

NCT01784822

Run by

Cook Group Incorporated

People needed

63

Starts

2013-02-01

Expected to finish

2016-06-01

Last updated by the study team

2017-06-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Tennessee — Knoxville, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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