A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer and Generator G11 in Upper Gastrointestinal, Lower Gastrointestinal, and Gynecological Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 8
- 主要终点
- Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
研究概览
简要总结
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal [GI], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
详细描述
The primary objective of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 Curved Jaw and Generator G11 devices when used per the instructions for use.
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
- •Primary laparoscopic or open procedure (upper gastrointestinal, lower gastrointestinal, or gynecological) where at least one vessel is planned to be transected by the ENSEAL X1 Curved Jaw device per the instructions for use;
- •Willingness to give consent and comply with all study-related evaluations and visit 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 interventional clinical study that could impact the study endpoints.
结局指标
主要结局
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
时间窗: On the day of transection (Day 0)
Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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 compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Number of Participants With Device-related Adverse Events (AEs)
时间窗: From Day 0 up to post-procedure follow up visit (up to 28 days)
Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices.
次要结局
- Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale(On the day of transection (Day 0))
- Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures(On the day of transection (Day 0))