Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application (SYN 20-01)

W.L. Gore & Associates

Status

Active, not recruiting

Conditions

Hernia Incisional Ventral

Hernia Incisional

Hernia, Ventral

Treatments

Device: Hernia repair with mesh

Study type

Observational

Funder types

Industry

Identifiers

NCT05094089

SYN 20-01

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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