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

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