Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- To confirm the safety for this device during inguinal/ femoral and ventral hernia repair procedures by assessing the proportion of subjects with SADE's/AEs
研究概览
简要总结
A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks
详细描述
A retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications:
- inguinal/femoral hernia
- ventral hernia
A minimum of 4 sites in the United States will perform chart review and enter 116 study records in the database for data collection. The 116 subject records will be comprised of 76 for the inguinal/femoral indication, and 40 for the ventral indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject underwent ventral or inguinal/femoral hernia repair procedure utilizing ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks on or after 510(k) approval.
- •Medical records are available, which document a ventral and/or inguinal/femoral hernia repair surgical procedure.
排除标准
- •Institutional Review Board (IRB) consent requirement cannot be met:
- •waiver of subject informed consent requirements are not granted by IRB* and,
- •an altercation to the consent process is not granted by the IRB and,
- •subject or subject's parent or legal guardian is unable or unwilling to provide signed informed consent
- •Subject was participating in any investigational drug or device study at the time of surgery or within 30-day (+3 days) study window
- •Subject was pregnant at the time of procedure
- •Subject had a documented allergy at the time of surgery to any of the components of the device or the mesh implant
- •Subject was treated with any other implantable mechanical fixation device, other than sutures
- •A waiver of subject informed consent procedures will be requested from all IRBs of record for this study.
结局指标
主要结局
To confirm the safety for this device during inguinal/ femoral and ventral hernia repair procedures by assessing the proportion of subjects with SADE's/AEs
时间窗: 30 days (+3 days) post procedure
Safety will be assessed as the proportion of subjects with SADE's/AEs
次要结局
- The rate of device-related malfunctions will be captured to confirm the performance for this device during inguinal/ femoral and ventral hernia repair procedures(30 days (+3 days) post procedure)