Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

Recruiting

• Conditions: Hernia, Ventral; Hernia Incisional Ventral; Hernia Incisional
• Interventions: Device: Hernia repair with mesh

• Registration Number: NCT05094089
• Lead Sponsor: W.L.Gore & Associates

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-26
• Study Start: 2023-02-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SYNECOR IP Device	Hernia repair with mesh	Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial
SYNECOR PRE Device	Hernia repair with mesh	Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial

Primary Outcome Measures

Name	Time	Method
Hernia Recurrence	60 Months	Hernia Recurrence Treated Location

Secondary Outcome Measures

Name	Time	Method
Freedom from mesh-involved events	60 Months	Freedom from mesh-involved events
Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up	60 Months	VHRI Survey (Ventral Hernia Recurrence Inventory)
Change in Quality of Life (QoL) - SF 36 Questionnaire	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)
Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)	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)
Adverse Events by Clavien Dindo Classification	60 Months	Adverse Events by Clavien Dindo Classification
Hospital Re-Admission	60 Months	Device or procedural-related
Major Seroma (clinically confirmed)	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.
Thirty-Day Mortality	30 Day	Mortality of all causes
SSI (Surgical Site Infection)	60 Months	Surgical Site Infection (SSI)
SSO within 24 months post-procedure	24 Months	Surgical Site Occurrence (SSO)
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	60 Months	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

Trial Locations

Locations (15)

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States

Lovelace Women's Hospital; 🇺🇸 Albuquerque, New Mexico, United States

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States

Prisma Health Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Novant Health New Hanover Regional Medical Center; 🇺🇸 Wilmington, North Carolina, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Bon Secours Memorial Regional Medical Center; 🇺🇸 Mechanicsville, Virginia, United States

Ospedale Civile di Baggiovara; 🇮🇹 Baggiovara, Italy

Vincenzo Monaldi Hospital; 🇮🇹 Napoli, Italy

Sapienza Università di Roma; 🇮🇹 Roma, Italy

University Hospital Virgen Macarena - Department of General And Digestive Surgery; 🇪🇸 Sevilla, Spain

Hospital Quirón Salud-Sagrado Corazón; 🇪🇸 Sevilla, Spain

Walsall Manor Hospital; 🇬🇧 Walsall, United Kingdom

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom