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Assessment of GORE® SYNECOR Biomaterial for Hernia Repair

Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

Observational W.L.Gore & Associates · NCT05094089

This study is testing a new type of mesh called GORE® SYNECOR Biomaterial to see if it helps people with ventral and incisional hernias heal better over five years.

Quick facts

Study typeObservational
Enrollment320 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorW.L.Gore & Associates Industry-sponsored
Locations15 sites (Atlanta, Georgia and 14 other locations)
Trial IDNCT05094089 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the use of GORE® SYNECOR Biomaterial in patients with ventral and incisional hernias suitable for mesh repair. It involves a multicenter, international approach, enrolling patients from both the US and EU cohorts. Participants will be followed for a period of 60 months to assess the long-term outcomes of the biomaterial in hernia repair. The study aims to gather data on the effectiveness and safety of this specific biomaterial in focused patient populations.

Who should consider this trial

Good fit: Ideal candidates include patients with de-novo ventral or incisional hernias that are clean and amenable to repair with the specified biomaterial.

Not a fit: Patients with contaminated or infected wounds will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the outcomes of hernia repair surgeries using GORE® SYNECOR Biomaterial.

How similar studies have performed: Other studies have shown promising results with similar biomaterials in hernia repair, suggesting potential for success in this investigation.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Atlanta, Georgia and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hernia, VentralHernia IncisionalHernia Incisional VentralHernia RepairHernia Mesh TreatmentVentral HerniaIncisional HerniaIntraperitoneal
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.