Clinical trial NCT05094089: Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Official title: Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hernia, Ventral
Hernia Incisional
Hernia Incisional Ventral
Keywords: Hernia Repair
Hernia Mesh Treatment
Ventral Hernia
Incisional Hernia
Intraperitoneal
Preperitoneal
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The SYN 20-01 study population will consist of patients who present with ventral/incisional hernia disease requiring treatment per the evaluating physician. Eligible study subjects need to be amenable to treatment with a permanent synthetic mesh as suggested by the inclusion and exclusion criteria for each study cohort.

Brief 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.


Eligibility criteria: Key Inclusion Criteria - IP Cohort:

* De-Novo ventral/incisional hernia amenable to repair with GORE® 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 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)

Key Exclusion Criteria - PRE Cohort:

- Wound is either clean-contaminated, contaminated or dirty-infected

Primary outcomes:
measure: Hernia Recurrence
timeFrame: 24 Months
measure: Hernia Recurrence
timeFrame: 60 Months
Secondary outcomes:
measure: Hospital Re-Admission
timeFrame: 60 Months
measure: Thirty-Day Mortality
timeFrame: 30 Day
measure: SSO within 24 months post-procedure
timeFrame: 24 Months
measure: SSI (Surgical Site Infection)
timeFrame: 60 Months
measure: Freedom from mesh-involved events
timeFrame: 60 Months
measure: Major Seroma (clinically confirmed)
timeFrame: 60 Months
measure: Change in Quality of Life (QoL) - SF 36 Questionnaire
timeFrame: 60 Months
measure: Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)
timeFrame: 60 Months
measure: Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
timeFrame: 60 Months
measure: Adverse Events by Clavien Dindo Classification
timeFrame: 60 Months
measure: Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
timeFrame: 24 Months
measure: Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
timeFrame: 60 Months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Albuquerque
country: United States
facility: Lovelace Women's Hospital
state: New Mexico
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Wilmington
country: United States
facility: Novant Health New Hanover Regional Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Mechanicsville
country: United States
facility: Bon Secours Memorial Regional Medical Center
state: Virginia
city: Baggiovara
country: Italy
facility: Ospedale Civile di Baggiovara
city: Napoli
country: Italy
facility: Vincenzo Monaldi Hospital
city: Roma
country: Italy
facility: Sapienza Università di Roma
city: Sevilla
country: Spain
facility: University Hospital Virgen Macarena - Department of General And Digestive Surgery
city: Sevilla
country: Spain
facility: Hospital Quirón Salud-Sagrado Corazón
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
Study officials:
References: