GORE® SYNECOR 生物材料在重点患者人群中的评估和长期应用 (SYN 20-01)
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
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Baggiovara、意大利、41126
- Ospedale Civile di Baggiovara
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Naples、意大利、80131
- Vincenzo Monaldi Hospital
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Roma、意大利、00189
- Sapienza Università di Roma
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Georgia
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Atlanta、Georgia、美国、30342
- Emory Saint Joseph's Hospital
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts Medical Center
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Michigan
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Grand Rapids、Michigan、美国、49506
- Corewell Health
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New Mexico
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Albuquerque、New Mexico、美国、87109
- Lovelace Women's Hospital
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New York
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Stony Brook、New York、美国、11794
- Stony Brook University Hospital
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North Carolina
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Wilmington、North Carolina、美国、28401
- Novant Health New Hanover Regional Medical Center
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South Carolina
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Greenville、South Carolina、美国、29605
- Prisma Health Greenville Memorial Hospital
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Virginia
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Mechanicsville、Virginia、美国、23116
- Bon Secours Memorial Regional Medical Center
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Birmingham、英国、B15 2GW
- University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
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Walsall、英国、WS2 9PS
- Walsall Manor Hospital
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Seville、西班牙、41009
- University Hospital Virgen Macarena - Department of General And Digestive Surgery
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Seville、西班牙、41013
- Hospital Quirón Salud-Sagrado Corazón
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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SYNECOR IP Device
Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial |
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery |
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SYNECOR PRE Device
Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial |
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hernia Recurrence
大体时间：24 Months
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Hernia Recurrence Treated Location |
24 Months
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Hernia Recurrence
大体时间：60 Months
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Hernia Recurrence Treated Location |
60 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hospital Re-Admission
大体时间：60 Months
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Device or procedural-related |
60 Months
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Thirty-Day Mortality
大体时间：30 Day
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Mortality of all causes |
30 Day
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SSO within 24 months post-procedure
大体时间：24 Months
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Surgical Site Occurrence (SSO) |
24 Months
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SSI (Surgical Site Infection)
大体时间：60 Months
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Surgical Site Infection (SSI) |
60 Months
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Freedom from mesh-involved events
大体时间：60 Months
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Freedom from mesh-involved events |
60 Months
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Major Seroma (clinically confirmed)
大体时间：60 Months
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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
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Change in Quality of Life (QoL) - SF 36 Questionnaire
大体时间：60 Months
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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
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Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)
大体时间：60 Months
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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
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Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
大体时间：60 Months
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VHRI Survey (Ventral Hernia Recurrence Inventory) |
60 Months
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Adverse Events by Clavien Dindo Classification
大体时间：60 Months
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Adverse Events by Clavien Dindo Classification |
60 Months
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Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
大体时间：24 Months
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Surgical Site Occurrences (SSOPI) requiring Procedural Intervention |
24 Months
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Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
大体时间：60 Months
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Surgical Site Occurrences (SSOPI) requiring Procedural Intervention |
60 Months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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