Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Launched by W.L.GORE & ASSOCIATES · Oct 22, 2021
Trial Information
Current as of May 29, 2025
Recruiting
Keywords
ClinConnect Summary
The SYN 20-01 Study is a clinical trial that is looking at a specific type of medical material called GORE® SYNECOR Biomaterial, which is used to help repair certain types of hernias, such as ventral and incisional hernias. This trial is designed for patients who are scheduled for surgery to fix their hernias and will take place in both the United States and Europe. Participants will be closely monitored for up to five years to see how well this material works in helping to heal their hernias.
To join the trial, participants need to be adults aged between 18 and 75 years old who have a new hernia that can be repaired with this special material. It's important that their wounds are clean and not infected. Participants can expect regular check-ups and follow-ups throughout the study period. This trial aims to gather valuable information about how effective the GORE® SYNECOR Biomaterial is in these specific patients over the long term, which could help improve treatment options for hernias in the future.
Gender
ALL
Eligibility criteria
- 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
About W.L.Gore & Associates
W.L. Gore & Associates is a pioneering medical device company renowned for its innovative contributions to the field of healthcare, particularly in vascular grafts, surgical meshes, and interventional devices. With a strong commitment to research and development, the company leverages advanced materials science to create products that enhance patient outcomes and improve the quality of care. W.L. Gore & Associates is dedicated to conducting clinical trials that rigorously evaluate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals worldwide. Through this commitment to excellence, the company aims to address unmet medical needs and advance the frontier of medical technology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Atlanta, Georgia, United States
Greenville, South Carolina, United States
Stony Brook, New York, United States
Albuquerque, New Mexico, United States
Walsall, , United Kingdom
Mechanicsville, Virginia, United States
Wilmington, North Carolina, United States
Baggiovara, , Italy
Sevilla, , Spain
Roma, , Italy
Birmingham, , United Kingdom
Napoli, , Italy
Albuquerque, New Mexico, United States
Grand Rapids, Michigan, United States
Sevilla, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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