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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hernia, Ventral; Hernia Incisional; Hernia Incisional Ventral
• Intervention / Treatment: Device: Hernia repair with mesh

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

Study Locations

• Italy
  • Baggiovara, Italy, 41126
    • Ospedale Civile di Baggiovara
  • Napoli, Italy, 80131
    • Vincenzo Monaldi Hospital
  • Roma, Italy, 00189
    • Sapienza università di Roma
• Spain
  • Seville, Spain, 41009
    • University Hospital Virgen Macarena - Department of General And Digestive Surgery
  • Seville, Spain, 41013
    • Hospital Quirón Salud-Sagrado Corazón
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
  • Walsall, United Kingdom, WS2 9PS
    • Walsall Manor Hospital
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49506
      • Corewell Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Lovelace Women's Hospital
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Novant Health New Hanover Regional Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Greenville Memorial Hospital
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Bon Secours Memorial Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The SYN 20-01 study population will consist of patients who present with ventral/incisional hernia disease requiring treatment per the evaluating physician. Eligible study subjects need to be amenable to treatment with a permanent synthetic mesh as suggested by the inclusion and exclusion criteria for each study cohort.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SYNECOR IP Device; Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial	Device: Hernia repair with mesh; Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
SYNECOR PRE Device; Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial	Device: Hernia repair with mesh; Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia Recurrence	Hernia Recurrence Treated Location	24 Months
Hernia Recurrence	Hernia Recurrence Treated Location	60 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Re-Admission	Device or procedural-related	60 Months
Thirty-Day Mortality	Mortality of all causes	30 Day
SSO within 24 months post-procedure	Surgical Site Occurrence (SSO)	24 Months
SSI (Surgical Site Infection)	Surgical Site Infection (SSI)	60 Months
Freedom from mesh-involved events	Freedom from mesh-involved events	60 Months
Major Seroma (clinically confirmed)	Major Seroma as clinically assessed (physiological parameters) and defined as seroma requiring treatment in the presence of infection, recurrence, mesh rejection or the need to be punctured/aspirated will be described without specific hypothesis or formal goal. Number of subjects with reported major seroma will be described as clinically confirmed by the investigator.	60 Months
Change in Quality of Life (QoL) - SF 36 Questionnaire	SF 36 Questionnaire (36-Item Short Form Survey Instrument; possible score ranges from 0 to 100 points. 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions)	60 Months
Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)	Carolinas Comfort Scale (CCS); CCS was designed that a lower score indicates a favorable health status; the total score is based on a scale of 0 - 115)	60 Months
Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up	VHRI Survey (Ventral Hernia Recurrence Inventory)	60 Months
Adverse Events by Clavien Dindo Classification	Adverse Events by Clavien Dindo Classification	60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	60 Months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Intraperitoneal; Preperitoneal; Ventral Hernia; Incisional Hernia; Hernia Repair; Hernia Mesh Treatment
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Incisional Hernia; Hernia, Ventral; Surgical Procedures, Operative; Plastic Surgery Procedures; Herniorrhaphy
• Other Study ID Numbers: SYN 20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes