Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05094089

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

HERNIA, VENTRAL Hernia Hernia Incisional Hernia Incisional Ventral Hernia, Abdominal Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Civile di Baggiovara, Baggiovara, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Hernia repair with mesh

Device

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

Primary outcomes

  1. Hernia Recurrence

    Time frame: 24 Months

    Hernia Recurrence Treated Location

  2. Hernia Recurrence

    Time frame: 60 Months

    Hernia Recurrence Treated Location

Secondary outcomes

  1. Hospital Re-Admission

    Time frame: 60 Months

    Device or procedural-related

  2. Thirty-Day Mortality

    Time frame: 30 Day

    Mortality of all causes

  3. SSO within 24 months post-procedure

    Time frame: 24 Months

    Surgical Site Occurrence (SSO)

  4. SSI (Surgical Site Infection)

    Time frame: 60 Months

    Surgical Site Infection (SSI)

  5. Freedom from mesh-involved events

    Time frame: 60 Months

    Freedom from mesh-involved events

  6. Major Seroma (clinically confirmed)

    Time frame: 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.

  7. Change in Quality of Life (QoL) - SF 36 Questionnaire

    Time frame: 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)

  8. Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)

    Time frame: 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)

  9. Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up

    Time frame: 60 Months

    VHRI Survey (Ventral Hernia Recurrence Inventory)

  10. Adverse Events by Clavien Dindo Classification

    Time frame: 60 Months

    Adverse Events by Clavien Dindo Classification

  11. Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

    Time frame: 24 Months

    Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

  12. Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

    Time frame: 60 Months

    Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Acronym: SYN 20-01

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Oct 26, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.