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

NCT05094089 · tracked via the Priya Life Science Spain tracker

Sponsor

W.L.Gore & Associates

Phase

Observational

Started

2023-02-24

Last updated

2026-01-21

Condition(s) studied

Hernia, VentralHernia IncisionalHernia Incisional Ventral

Investigational drug(s) / intervention(s)

Hernia repair with mesh

Hernia repair with mesh: Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery

Study summary

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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Hernia Recurrence — 24 Months
Hernia Recurrence Treated Location
Hernia Recurrence — 60 Months
Hernia Recurrence Treated Location

Trial sites (15)

Facility	City	Region
Emory Saint Joseph's Hospital	Atlanta	Georgia
Tufts Medical Center	Boston	Massachusetts
Corewell Health	Grand Rapids	Michigan
Lovelace Women's Hospital	Albuquerque	New Mexico
Stony Brook University Hospital	Stony Brook	New York
Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina
Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
Bon Secours Memorial Regional Medical Center	Mechanicsville	Virginia
Ospedale Civile di Baggiovara	Baggiovara	Italy
Vincenzo Monaldi Hospital	Naples	Italy
Sapienza Università di Roma	Roma	Italy
University Hospital Virgen Macarena - Department of General And Digestive Surgery	Seville	Spain
Hospital Quirón Salud-Sagrado Corazón	Seville	Spain
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham	Birmingham	United Kingdom
Walsall Manor Hospital	Walsall	United Kingdom

More W.L.Gore & Associates trials in Spain

VIATORR Device Registry Active, not recruiting

Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries Active, not recruiting

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis Active, not recruiting

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis Recruiting

Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels Active, not recruiting

Other trials for the same condition

Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05094089 on ClinicalTrials.gov ↗ ← All trials in Spain