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Biomaterial

SYNECOR PRE Device for Ventral Hernia (SYN 20-01 Trial)

N/A
Recruiting
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

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.

Eligible Conditions
  • Ventral Hernia
  • Incisional Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hernia Recurrence
Secondary study objectives
Adverse Events by Clavien Dindo Classification
Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)
Change in Quality of Life (QoL) - SF 36 Questionnaire
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SYNECOR PRE DeviceExperimental Treatment1 Intervention
Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial
Group II: SYNECOR IP DeviceExperimental Treatment1 Intervention
Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial

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Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
98 Previous Clinical Trials
28,524 Total Patients Enrolled
~141 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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