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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral

Intervention / Treatment
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* Device: Hernia repair with mesh


Participation Criteria
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Eligibility Criteria
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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 is 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SYNECOR IP Device<br>Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial | Device: Hernia repair with mesh<br>* Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery<br>|
| SYNECOR PRE Device<br>Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial | Device: Hernia repair with mesh<br>* Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia Recurrence | Hernia Recurrence Treated Location | 24 Months | 
| Hernia Recurrence | Hernia Recurrence Treated Location | 60 Months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia Repair, Hernia Mesh Treatment, Ventral Hernia, Incisional Hernia, Intraperitoneal, Preperitoneal