Assessment of GOREĀ® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application (NCT05094089) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Assessment of GOREĀ® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
United States320 participantsStarted 2023-02-24
Plain-language summary
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GOREĀ® 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.
Who can participate
Age range18 Years ā 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria - IP Cohort:
* De-Novo ventral/incisional hernia amenable to repair with GOREĀ® 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 GOREĀ® 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