A Multi-Center Evaluation of the ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 15
- 主要终点
- Number of Participants with Select Device-related Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (Video-Assisted Thoracoscopic [ATS] or open approach).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult and pediatric participants satisfying the following criteria will be considered eligible for enrollment in this study (procedures may be performed with or without a robot): Primary procedure where the ECHELON 3000 Stapler and reload system is planned to be used for tissue transection per the instructions for use (IFU) in either of the following, a) Laparoscopic Sleeve Gastrectomy; b) Lung resection procedures (VATS or open)
- •Adult participants- Willingness to give consent and comply with all study-related evaluations and visit schedule
- •Pediatric participants- The participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide documented informed consent for the participants. In addition, assent must be obtained from pediatric participant who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric participant 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 documented informed consent for the participant will be acceptable for the participant to be included in the study
排除标准
- •Physical or psychological condition which would impair study participation
- •Procedure is a revision/reoperation for the same indication or same anatomical location
- •A procedure where surgical stapling is contraindicated
- •Concurrent treatment with medications that the investigator deems could have influence on wound healing
- •Enrollment in a concurrent interventional clinical study that could impact the study endpoints
研究组 & 干预措施
ECHELON 3000 Stapler
This prospective study will include the participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure and collect clinical data in a post-market setting. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON 3000 Stapler and reloads instructions for use (IFU).
干预措施: ECHELON 3000 Stapler (Device)
结局指标
主要结局
Number of Participants with Select Device-related Serious Adverse Events (SAEs)
时间窗: 30 days post procedure
An adverse event (AE) is defined as any untoward medical occurrence, regardless of its relationship to study device or study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of pre-existing condition, which occurs throughout the duration of the clinical study. SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect. The device-related SAEs that will be captured are infection or symptoms of infection, bleeding, gastric leak (laparoscopic sleeve gastrectomy \[LSG\] only), and postoperative air leak (lung resection only).
次要结局
- Number of Participants with All Device-related, Procedure-related SAEs(30 days post-procedure)
- Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)(30 days post-procedure)