NCT05094089

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
4 countries

15 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Feb 2023Jul 2030

First Submitted

Initial submission to the registry

October 5, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

7.4 years

First QC Date

October 5, 2021

Last Update Submit

January 16, 2026

Conditions

Hernia, VentralHernia IncisionalHernia Incisional Ventral

Keywords

Hernia RepairHernia Mesh TreatmentVentral HerniaIncisional HerniaIntraperitonealPreperitoneal

Outcome Measures

Primary Outcomes (2)

  • Hernia Recurrence

    Hernia Recurrence Treated Location

    24 Months

  • Hernia Recurrence

    Hernia Recurrence Treated Location

    60 Months

Secondary Outcomes (12)

  • Hospital Re-Admission

    60 Months

  • Thirty-Day Mortality

    30 Day

  • SSO within 24 months post-procedure

    24 Months

  • SSI (Surgical Site Infection)

    60 Months

  • Freedom from mesh-involved events

    60 Months

  • +7 more secondary outcomes

Study Arms (2)

SYNECOR IP Device

Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial

Device: Hernia repair with mesh

SYNECOR PRE Device

Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial

Device: Hernia repair with mesh

Interventions

Hernia repair with meshDEVICE

Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery

SYNECOR IP DeviceSYNECOR PRE Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • \- Wound is either clean-contaminated, contaminated or dirty-infected
  • 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)
  • \- Wound is either clean-contaminated, contaminated or dirty-infected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Corewell Health

Grand Rapids, Michigan, 49506, United States

Location

Lovelace Women's Hospital

Albuquerque, New Mexico, 87109, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

Location

Ospedale Civile di Baggiovara

Baggiovara, 41126, Italy

Location

Vincenzo Monaldi Hospital

Naples, 80131, Italy

Location

Sapienza Università di Roma

Roma, 00189, Italy

Location

University Hospital Virgen Macarena - Department of General And Digestive Surgery

Seville, 41009, Spain

Location

Hospital Quirón Salud-Sagrado Corazón

Seville, 41013, Spain

Location

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

Location

Walsall Manor Hospital

Walsall, WS2 9PS, United Kingdom

Location

MeSH Terms

Conditions

Hernia, VentralIncisional Hernia

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 26, 2021

Study Start

February 24, 2023

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)GB(2)ES(2)US(8)