Hernia, VentralSYN 20-01NCT05094089
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
An observational study of Hernia, Ventral and Hernia Incisional, run by W.L.Gore & Associates at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral
- What is being tested?
- Hernia repair with mesh
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 24 Feb 2023to 31 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
- 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)
Who cannot join
- Wound is either clean-contaminated, contaminated or dirty-infected
- Wound is either clean-contaminated, contaminated or dirty-infected
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States8 sites
Lovelace Women's Hospital
Albuquerque, New Mexico, 87109
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Tufts Medical Center
Boston, Massachusetts, 02111
Corewell Health
Grand Rapids, Michigan, 49506
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Stony Brook University Hospital
Stony Brook, New York, 11794
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Italy3 sites
Ospedale Civile di Baggiovara
Baggiovara, 41126
Vincenzo Monaldi Hospital
Naples, 80131
Sapienza Università di Roma
Roma, 00189
Spain2 sites
University Hospital Virgen Macarena - Department of General And Digestive Surgery
Seville, 41009
Hospital Quirón Salud-Sagrado Corazón
Seville, 41013
United Kingdom2 sites
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Walsall Manor Hospital
Walsall, WS2 9PS
About this study
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.
- Being tested
- Hernia repair with mesh
- Keywords
- Hernia Repair, Hernia Mesh Treatment, Ventral Hernia, Incisional Hernia, Intraperitoneal, Preperitoneal
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia repair with meshDevice
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| SYNECOR IP Device | Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial Receives: Device: Hernia repair with mesh | |
| SYNECOR PRE Device | Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial Receives: Device: Hernia repair with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence
Hernia Recurrence Treated Location
Measured: 24 Months
Hernia Recurrence
Hernia Recurrence Treated Location
Measured: 60 Months
Secondary outcomes (12)
Hospital Re-Admission
Device or procedural-related
Measured: 60 Months
Thirty-Day Mortality
Mortality of all causes
Measured: 30 Day
SSO within 24 months post-procedure
Surgical Site Occurrence (SSO)
Measured: 24 Months
SSI (Surgical Site Infection)
Surgical Site Infection (SSI)
Measured: 60 Months
Freedom from mesh-involved events
Freedom from mesh-involved events
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 60 Months
Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
VHRI Survey (Ventral Hernia Recurrence Inventory)
Measured: 60 Months
Adverse Events by Clavien Dindo Classification
Adverse Events by Clavien Dindo Classification
Measured: 60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Measured: 24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start24 Feb 2023
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094089
- Sponsor's protocol ID
- SYN 20-01
- Acronym
- SYN 20-01
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
- ClinicalTrials.gov ID
- NCT05094089
- Acronym / sponsor ID
- SYN 20-01 / SYN 20-01
- Keywords
- Hernia Repair, Hernia Mesh Treatment, Ventral Hernia, Incisional Hernia, Intraperitoneal, Preperitoneal
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNECOR IP Device | – | Device: Hernia repair with meshHernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial |
| SYNECOR PRE Device | – | Device: Hernia repair with meshHernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
- 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)
Key exclusion criteria (2 listed)
- Wound is either clean-contaminated, contaminated or dirty-infected
- Wound is either clean-contaminated, contaminated or dirty-infected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hernia repair with meshHernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery | Device | SYNECOR IP Device, SYNECOR PRE Device |
Primary outcome
Hernia Recurrence
Time frame: 24 Months
Hernia Recurrence Treated Location
Hernia Recurrence
Time frame: 60 Months
Hernia Recurrence Treated Location
12 secondary outcomes
Hospital Re-Admission
Time frame: 60 Months
Thirty-Day Mortality
Time frame: 30 Day
SSO within 24 months post-procedure
Time frame: 24 Months
SSI (Surgical Site Infection)
Time frame: 60 Months
Freedom from mesh-involved events
Time frame: 60 Months
Major Seroma (clinically confirmed)
Time frame: 60 Months
Change in Quality of Life (QoL) - SF 36 Questionnaire
Time frame: 60 Months
Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)
Time frame: 60 Months
Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
Time frame: 60 Months
Adverse Events by Clavien Dindo Classification
Time frame: 60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time frame: 24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time frame: 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Ventral and Hernia Incisional, run by W.L.Gore & Associates at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.