MicroCutter Assisted Thoracic Surgery Hemostasis Registry
试验速览
- 阶段
- 不适用
- 发起方
- AesDex, LLC
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemostasis of vessel staple line
研究概览
简要总结
The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic surgery (VATS) including robotic surgical cases. Clinicians will provide objective and subjective evaluation of the use of the stapler in their procedures.
详细描述
The MATCH registry is a prospective, open label, multi-center observational registry with enrollment of patients requiring surgical stapling during a lobectomy or segmentectomy. Patients will be treated per the clinicians standard of care with medical history and demographic data collected pre-procedure, operative data including clinician's objective and subjective evaluation of the stapler and confirmation of any complications via query and data collection at hospital discharge and each clinician's standard post-operative contact.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lobectomy/segmentectomy in which the MicroCutter Stapler and Reloads were used.
- •Patient is willing and able to sign informed consent form to participate in registry, allowing for collection of data.
排除标准
- •Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.
结局指标
主要结局
Hemostasis of vessel staple line
时间窗: through study completion, approximately 1 month
Objective classification of hemostasis achieved by the MicroCutter Stapler used on label using a Likert like scale; from 1 (no bleeding) to 5 (bleeding requiring conversion to open procedure or discovered post operatively)
次要结局
未报告次要终点