Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
Completed
- Conditions
- Ventral Hernias
- Interventions
- Device: Zenapro™ Hybrid Hernia Repair Device
- Registration Number
- NCT01784822
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Zenapro™ Hybrid Hernia Repair Device Zenapro™ Hybrid Hernia Repair Device Device to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias.
- Primary Outcome Measures
Name Time Method Rate of hernia recurrence 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Duke University
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States