A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears and Generator G11 in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 11
- 主要终点
- Number of Vessels Transected 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 for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 1100 Shears and Generator G11 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric population:
- •Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
- •Less than 18 years of age at the time of procedure; and
- •The subject's parent/legal guardian must be willing to give permission for the subject to participate in the study and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study.
- •Adult population:
- •Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
- •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
- •Preoperative
- •Physical or psychological condition which would impair study participation;
- •Female subjects, of childbearing age, who are pregnant; or
- •Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
- •Intraoperative
- •1. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.
结局指标
主要结局
Number of Vessels Transected 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 transected 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 HARMONIC 1100 Shears; 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 device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt.
次要结局
- Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale(On the day of transection (Day 0))
- Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score(On the day of transection (Day 0))
- Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale(On the day of transection (Day 0))
- Number of Grade 4 Vessel Transections Requiring Hemostasis Measures(On the day of transection (Day 0))