NCT05094089进行中（未招募）不适用
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
W.L.Gore & Associates15 个研究点 分布在 4 个国家目标入组 320 人开始时间: 2023年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
- 试验地点
- 15
- 主要终点
- Hernia Recurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Hernia Recurrence
时间窗: 60 Months
Hernia Recurrence Treated Location
次要结局
- Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up(60 Months)
- Freedom from mesh-involved events(60 Months)
- Change in Quality of Life (QoL) - SF 36 Questionnaire(60 Months)
- Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)(60 Months)
- Adverse Events by Clavien Dindo Classification(60 Months)
- Hospital Re-Admission(60 Months)
- Major Seroma (clinically confirmed)(60 Months)
- Thirty-Day Mortality(30 Day)
- SSI (Surgical Site Infection)(60 Months)
- SSO within 24 months post-procedure(24 Months)
- Surgical Site Occurrences (SSOPI) requiring Procedural Intervention(60 Months)
研究者
研究点 (15)
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