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

March 16, 2024 updated by: W.L.Gore & Associates

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
  • Spain
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Quirón Salud-Sagrado Corazón
        • Contact:
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
        • Contact:
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Ankit Patel, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Grand Rapids, Michigan, United States, 49506
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Lovelace Women's Hospital
        • Contact:
        • Principal Investigator:
          • Michael Blea, MD
    • New York
      • Stony Brook, New York, United States, 11794
    • North Carolina
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Greenville Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Alfredo Carbonell, MD
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Amit Gogia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 24 Months
Hernia Recurrence Treated Location
24 Months
Hernia Recurrence
Time Frame: 60 Months
Hernia Recurrence Treated Location
60 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Re-Admission
Time Frame: 60 Months
Device or procedural-related
60 Months
Thirty-Day Mortality
Time Frame: 30 Day
Mortality of all causes
30 Day
SSO within 24 months post-procedure
Time Frame: 24 Months
Surgical Site Occurrence (SSO)
24 Months
SSI (Surgical Site Infection)
Time Frame: 60 Months
Surgical Site Infection (SSI)
60 Months
Freedom from mesh-involved events
Time Frame: 60 Months
Freedom from mesh-involved events
60 Months
Major Seroma (clinically confirmed)
Time Frame: 60 Months
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
Time Frame: 60 Months
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)
Time Frame: 60 Months
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
Time Frame: 60 Months
VHRI Survey (Ventral Hernia Recurrence Inventory)
60 Months
Adverse Events by Clavien Dindo Classification
Time Frame: 60 Months
Adverse Events by Clavien Dindo Classification
60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time Frame: 24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time Frame: 60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
60 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2028

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)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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