A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 12
- 主要终点
- Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1
研究概览
简要总结
This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.
详细描述
The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
- •Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
- •At least 18 years of age.
排除标准
- •Physical or psychological condition which would impair study participation; or
- •Enrollment in a concurrent clinical study.
结局指标
主要结局
Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1
时间窗: Intraoperative, after vessel has been transected
* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
次要结局
- Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used(Intraoperative, after vessel has been transected)
- Hemostasis Grading Assessment for Each Vessel Transection(Intraoperative, after vessel has been transected)
- Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up(Intraoperative, after vessel has been transected)