Overview
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application.
Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.
Eligibility
Key Inclusion Criteria - IP Cohort:
- De-Novo ventral/incisional hernia amenable to repair with GORE® SYNECOR IP Biomaterial
- Clean wound (CDC Wound Class I)
- mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)
Key Exclusion Criteria - IP Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
Key Inclusion Criteria - PRE Cohort:
- De-novo ventral/incisional hernia, with subject anatomy and surgical plan amenable to open surgical repair or minimally invasive surgery with the GORE® SYNECOR PRE Biomaterial placed in a sublay fashion within the preperitoneal space
- Clean wound (CDC Wound Class I)
- mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)
Key Exclusion Criteria - PRE Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected