This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.
This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh
Anne Arundel Medical Center
Annapolis, Maryland, United States
Hernia Recurrence
Time frame: One year
Quality of Life
Time frame: One year
Hernia associated pain and movement limitations pre-surgery compared to post-surgery
Time frame: One year
Reoperation Rate
Time frame: One year
Percutaneous Intervention Rate
Time frame: One year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability"
Time frame: One year
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