SYN 20-01: Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05094089
• Collaborator: (none)
• Enrollment: 320
• Anticipated Duration (Months): 76

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Ventral; Hernia Incisional; Hernia Incisional Ventral	Device: Hernia repair with mesh

Study Design

• Study Type: Observational
• Anticipated Enrollment: 320 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
• Anticipated Study Start Date: Aug 31, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
SYNECOR IP Device Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial	Device: Hernia repair with mesh; Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
SYNECOR PRE Device Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial	Device: Hernia repair with mesh; Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery

Outcome Measures

Primary Outcome Measures

1. Hernia Recurrence [24 Months]

   Hernia Recurrence Treated Location

2. Hernia Recurrence [60 Months]

   Hernia Recurrence Treated Location

Secondary Outcome Measures

1. Hospital Re-Admission [60 Months]

   Device or procedural-related

2. Thirty-Day Mortality [30 Day]

   Mortality of all causes

3. SSO within 24 months post-procedure [24 Months]

   Surgical Site Occurrence (SSO)

4. SSI (Surgical Site Infection) [60 Months]

   Surgical Site Infection (SSI)

5. Freedom from mesh-involved events [60 Months]

   Freedom from mesh-involved events

6. Major Seroma (clinically confirmed) [60 Months]

   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.

7. Change in Quality of Life (QoL) - SF 36 Questionnaire [60 Months]

   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)

8. Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS) [60 Months]

   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)

9. Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up [60 Months]

   VHRI Survey (Ventral Hernia Recurrence Inventory)

10. Adverse Events by Clavien Dindo Classification [60 Months]

    Adverse Events by Clavien Dindo Classification

11. Surgical Site Occurrences (SSOPI) requiring Procedural Intervention [24 Months]

    Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

12. Surgical Site Occurrences (SSOPI) requiring Procedural Intervention [60 Months]

    Surgical Site Occurrences (SSOPI) requiring Procedural Intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 is 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT05094089
• Other Study ID Numbers: SYN 20-01
• First Posted: Oct 26, 2021
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by W.L.Gore & Associates: Hernia Repair; Hernia Mesh Treatment; Ventral Hernia; Incisional Hernia; Intraperitoneal; Preperitoneal
• Additional relevant MeSH terms: Hernia; Hernia, Ventral; Incisional Hernia

Study Results

No Results Posted as of Jul 5, 2022