NCT05094089

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2023-02-24
• Primary completion: 2030-07-31
• Completion: 2030-07-31
• First posted: 2021-10-26
• Last updated: 2026-01-21

Locations

15 sites across 4 countries: United States, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study