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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNECOR IP Device | Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial |
| |
| SYNECOR PRE Device | Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hernia repair with mesh | Device | Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence | Hernia Recurrence Treated Location | 24 Months |
| Hernia Recurrence | Hernia Recurrence Treated Location | 60 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Re-Admission | Device or procedural-related | 60 Months |
| Thirty-Day Mortality | Mortality of all causes | 30 Day |
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Key Inclusion Criteria - IP Cohort:
Key Exclusion Criteria - IP Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
Key Inclusion Criteria - PRE Cohort:
Key Exclusion Criteria - PRE Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States | ||
| Tufts Medical Center |
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| SSO within 24 months post-procedure | Surgical Site Occurrence (SSO) | 24 Months |
| SSI (Surgical Site Infection) | Surgical Site Infection (SSI) | 60 Months |
| Freedom from mesh-involved events | Freedom from mesh-involved events | 60 Months |
| 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 |
| 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 |
| 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 |
| Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up | VHRI Survey (Ventral Hernia Recurrence Inventory) | 60 Months |
| Adverse Events by Clavien Dindo Classification | Adverse Events by Clavien Dindo Classification | 60 Months |
| Surgical Site Occurrences (SSOPI) requiring Procedural Intervention | Surgical Site Occurrences (SSOPI) requiring Procedural Intervention | 24 Months |
| Surgical Site Occurrences (SSOPI) requiring Procedural Intervention | Surgical Site Occurrences (SSOPI) requiring Procedural Intervention | 60 Months |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| Corewell Health | Grand Rapids | Michigan | 49506 | United States |
| Lovelace Women's Hospital | Albuquerque | New Mexico | 87109 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Novant Health New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Bon Secours Memorial Regional Medical Center | Mechanicsville | Virginia | 23116 | United States |
| Ospedale Civile di Baggiovara | Baggiovara | 41126 | Italy |
| Vincenzo Monaldi Hospital | Naples | 80131 | Italy |
| Sapienza Università di Roma | Roma | 00189 | Italy |
| University Hospital Virgen Macarena - Department of General And Digestive Surgery | Seville | 41009 | Spain |
| Hospital Quirón Salud-Sagrado Corazón | Seville | 41013 | Spain |
| University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham | Birmingham | B15 2GW | United Kingdom |
| Walsall Manor Hospital | Walsall | WS2 9PS | United Kingdom |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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