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

NCT05094089 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2026-01-21

No results posted yet for this study

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.

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.

Conditions

  • Hernia, Ventral
  • Hernia Incisional
  • Hernia Incisional Ventral

Interventions

DEVICE

Hernia repair with mesh

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

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-24
Primary Completion
2030-07-31
Completion
2030-07-31
FDA Device
Yes

Countries

  • United States
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05094089 on ClinicalTrials.gov