Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
NCT ID: NCT05094089
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
320 participants
OBSERVATIONAL
2023-02-24
2030-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SYNECOR IP Device
Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial
Hernia repair with mesh
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
SYNECOR PRE Device
Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial
Hernia repair with mesh
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
Interventions
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Hernia repair with mesh
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
\- Wound is either clean-contaminated, contaminated or dirty-infected
18 Years
80 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Locations
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Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Tufts Medical Center
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Lovelace Women's Hospital
Albuquerque, New Mexico, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Ospedale Civile di Baggiovara
Baggiovara, , Italy
Vincenzo Monaldi Hospital
Napoli, , Italy
Sapienza Università di Roma
Roma, , Italy
University Hospital Virgen Macarena - Department of General And Digestive Surgery
Seville, , Spain
Hospital Quirón Salud-Sagrado Corazón
Seville, , Spain
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Walsall Manor Hospital
Walsall, , United Kingdom
Countries
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Other Identifiers
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SYN 20-01
Identifier Type: -
Identifier Source: org_study_id
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