Grade II Ventral Hernia, Grade I Ventral Hernia
Conditions
Keywords
hernia, synthetic mesh
Brief summary
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.
Detailed description
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.
Interventions
DEVICESymbotex™ Composite Mesh
Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh
Sponsors
Medtronic - MITG
Anne Arundel Health System Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Grade I or II ventral hernia according to VHWG classification system * Pre-operative informed consent is obtainable
Exclusion criteria
* Not candidate for laparoscopic approach for repair of their hernia * Determination in the operating room that biologic mesh is needed over permanent mesh * Fascial defect less than 3 cm in greatest dimension * Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed * Grade III or IV ventral hernia according to VHWG system * ASA score IV or above * Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation. * Pregnancy * Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hernia Recurrence | One year |
| Quality of Life | One year |
| Hernia associated pain and movement limitations pre-surgery compared to post-surgery | One year |
| Reoperation Rate | One year |
| Percutaneous Intervention Rate | One year |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | One year |
Countries
United States
Outcome results
None listed