An observational study in Hernia, Ventral, Hernia Incisional and Hernia Incisional Ventral, sponsored by W.L.Gore & Associates. Active, not recruiting at 15 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by W.L.Gore & Associates · Observational
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.
254 studies on the registry are indexed under Hernia, Ventral; 46 are open to participants now.
This study's planned enrollment of 320 is above the median of 143 across 81 observational studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Key Inclusion Criteria - IP Cohort:
Key Exclusion Criteria - IP Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
Key Inclusion Criteria - PRE Cohort:
Key Exclusion Criteria - PRE Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial
Device: Hernia repair with mesh
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
Hernia Recurrence
Hernia Recurrence Treated Location
Time frame: 24 Months
Hernia Recurrence
Hernia Recurrence Treated Location
Time frame: 60 Months
Hospital Re-Admission
Device or procedural-related
Time frame: 60 Months
Thirty-Day Mortality
Mortality of all causes
Time frame: 30 Day
SSO within 24 months post-procedure
Surgical Site Occurrence (SSO)
Time frame: 24 Months
SSI (Surgical Site Infection)
Surgical Site Infection (SSI)
Time frame: 60 Months
Freedom from mesh-involved events
Freedom from mesh-involved events
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 60 Months
Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
VHRI Survey (Ventral Hernia Recurrence Inventory)
Time frame: 60 Months
Adverse Events by Clavien Dindo Classification
Adverse Events by Clavien Dindo Classification
Time frame: 60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time frame: 24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time frame: 60 Months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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W.L.Gore & Associates