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

Last updated: April 2, 2025
Sponsor: W.L.Gore & Associates
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Hernia repair with mesh

Clinical Study ID

NCT05094089
SYN 20-01
  • Ages 18-80
  • All Genders

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 Criteria

Inclusion

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 Design

Total Participants: 320
Treatment Group(s): 1
Primary Treatment: Hernia repair with mesh
Phase:
Study Start date:
February 24, 2023
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Ospedale Civile di Baggiovara

    Baggiovara, 41126
    Italy

    Active - Recruiting

  • Vincenzo Monaldi Hospital

    Napoli, 80131
    Italy

    Active - Recruiting

  • Sapienza Università di Roma

    Roma, 00189
    Italy

    Active - Recruiting

  • Hospital Quirón Salud-Sagrado Corazón

    Sevilla, 41013
    Spain

    Active - Recruiting

  • University Hospital Virgen Macarena - Department of General And Digestive Surgery

    Sevilla, 41009
    Spain

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Walsall Manor Hospital

    Walsall, WS2 9PS
    United Kingdom

    Active - Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49506
    United States

    Site Not Available

  • Lovelace Women's Hospital

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia 23116
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.