Suspended

SYN 20-01GORE® SYNECOR Biomaterial Assessment in Ventral/Incisional Hernia Repair

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Study Aim

This observational study aims to assess the recurrence of hernias at the treated location in individuals who have undergone ventral/incisional hernia repair using the GORE® SYNECOR Biomaterial.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Incisional Hernia+5

+ Hernia

+ Hernia, Ventral

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2023
See protocol details

Summary

Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 24, 2023

Actual date on which the first participant was enrolled.

The study focuses on evaluating the use of GORE® SYNECOR Biomaterial in patients with a specific type of hernia, known as ventral or incisional hernia. These hernias can be treated with a mesh repair. The goal is to understand how this biomaterial works in certain patient groups and over an extended period. This research is important as it aims to improve treatment options and patient care for those suffering from these types of hernias. In this study, participants with ventral or incisional hernias will undergo mesh repair using the GORE® SYNECOR Biomaterial. They will be divided into two groups, one from the US and the other from the EU, and will be monitored for a period of 60 months. The main outcome being measured is hernia recurrence at the treated location. This helps to determine the effectiveness and safety of the GORE® SYNECOR Biomaterial in the long term.

Official TitleAssessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
NCT05094089
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

320 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Incisional HerniaHerniaHernia, VentralPathologic ProcessesPostoperative ComplicationsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, Abdominal

Criteria

6 inclusion criteria required to participate
mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)
De-Novo ventral/incisional hernia amenable to repair with GORE® SYNECOR IP Biomaterial
Clean wound (CDC Wound Class I)
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
Show More Criteria
2 exclusion criteria prevent from participating
Wound is either clean-contaminated, contaminated or dirty-infected
Wound is either clean-contaminated, contaminated or dirty-infected

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

Vincenzo Monaldi Hospital

Napoli, ItalyOpen Vincenzo Monaldi Hospital in Google Maps
Suspended

Sapienza Università di Roma

Roma, Italy
Suspended

University Hospital Virgen Macarena - Department of General And Digestive Surgery

Seville, Spain
Suspended

Hospital Quirón Salud-Sagrado Corazón

Seville, Spain
Suspended15 Study Centers