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

Hernia, Ventral Clinical Trial

— SYN 20-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094089
• Other study ID #: SYN 20-01
• Status: Recruiting
• Start date: February 24, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: W.L.Gore & Associates
• Contact: Heidie Hornstra O'Neill
• Phone: +14439073152
• Email: hhornstr[@]wlgore.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Hernia Incisional Ventral
• Hernia, Ventral
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Civile di Baggiovara	Baggiovara
Italy	Vincenzo Monaldi Hospital	Napoli
Italy	Sapienza Università di Roma	Roma
Spain	Hospital Quirón Salud-Sagrado Corazón	Sevilla
United Kingdom	University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham	Birmingham
United States	Lovelace Women's Hospital	Albuquerque	New Mexico
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Tufts Medical Center	Boston	Massachusetts
United States	Corewell Health	Grand Rapids	Michigan
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Bon Secours Memorial Regional Medical Center	Mechanicsville	Virginia
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Novant Health New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia Recurrence	Hernia Recurrence Treated Location	24 Months
Primary	Hernia Recurrence	Hernia Recurrence Treated Location	60 Months
Secondary	Hospital Re-Admission	Device or procedural-related	60 Months
Secondary	Thirty-Day Mortality	Mortality of all causes	30 Day
Secondary	SSO within 24 months post-procedure	Surgical Site Occurrence (SSO)	24 Months
Secondary	SSI (Surgical Site Infection)	Surgical Site Infection (SSI)	60 Months
Secondary	Freedom from mesh-involved events	Freedom from mesh-involved events	60 Months
Secondary	Major Seroma (clinically confirmed)	Major Seroma as clinically assessed (physiological parameters) and defined as seroma requiring treatment in the presence of infection, recurrence, mesh rejection or the need to be punctured/aspirated will be described without specific hypothesis or formal goal. Number of subjects with reported major seroma will be described as clinically confirmed by the investigator.	60 Months
Secondary	Change in Quality of Life (QoL) - SF 36 Questionnaire	SF 36 Questionnaire (36-Item Short Form Survey Instrument; possible score ranges from 0 to 100 points. 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions)	60 Months
Secondary	Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)	Carolinas Comfort Scale (CCS); CCS was designed that a lower score indicates a favorable health status; the total score is based on a scale of 0 - 115)	60 Months
Secondary	Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up	VHRI Survey (Ventral Hernia Recurrence Inventory)	60 Months
Secondary	Adverse Events by Clavien Dindo Classification	Adverse Events by Clavien Dindo Classification	60 Months
Secondary	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	24 Months
Secondary	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	Surgical Site Occurrences (SSOPI) requiring Procedural Intervention	60 Months