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New mesh study aims to reduce hernia recurrence over 5 years

NCT ID NCT05094089

Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 320 people who had ventral or incisional hernia repair using GORE SYNECOR biomaterial mesh. Researchers will track hernia recurrence, infections, and other complications for up to 5 years. The goal is to see how well the mesh works in real-world settings across the US and Europe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GORE SYNECOR biomaterial mesh
What this could lead to
If successful, this study could confirm that GORE SYNECOR mesh is safe and effective for long-term hernia repair, reducing recurrence and complications.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Hernia recurrence or mesh-related issues could still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hernia, Ventral Incisional Hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hernia incisional Hernia incisional ventral Hernia, ventral

Contacts and locations

Locations

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116, United States

  • Corewell Health

    Grand Rapids, Michigan, 49506, United States

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Hospital Quirón Salud-Sagrado Corazón

    Seville, 41013, Spain

  • Lovelace Women's Hospital

    Albuquerque, New Mexico, 87109, United States

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401, United States

  • Ospedale Civile di Baggiovara

    Baggiovara, 41126, Italy

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605, United States

  • Sapienza Università di Roma

    Roma, 00189, Italy

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

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

    Seville, 41009, Spain

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

    Birmingham, B15 2GW, United Kingdom

  • Vincenzo Monaldi Hospital

    Naples, 80131, Italy

  • Walsall Manor Hospital

    Walsall, WS2 9PS, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.