A Prospective, Single-Arm, Multi-Center Study of the ECHELON ENDOPATH(TM) Staple Line Reinforcement Device in Gastric and Lung Resection Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
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 two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.
详细描述
The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.
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 procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b:
- •Gastric procedures limited to laparoscopic gastric resection, robotic laparoscopic gastric resection, partial gastrectomy, gastric wedge resection, subtotal gastrectomy, laparoscopic Roux-en-Y gastric bypass, and robotic laparoscopic gastric bypass; or
- •Lung resection procedures that include lobectomy, segmentectomy or wedge resection, and lung volume reduction surgery, and may be video assisted thoracic surgery (VATS) or open procedures;
- •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;
- •Body mass index (BMI) ≥ 46.0 kg/m2;
- •The procedure is a revision/reoperation for the same indication or same anatomical location;
- •A procedure where extended wound or organ support is required;
- •Any medical condition that the investigator deems could impact inflammatory or immune response;
- •Concurrent treatment with medications that the investigator deems could have influence on wound healing;
- •History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
- •Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
- •Intraoperative:
- •Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.
结局指标
主要结局
Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
时间窗: From Day 0 (day of surgery) through 70 days post-surgery
Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line).
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days
时间窗: From Day 0 (day of surgery) through 70 days post-surgery
Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema).
次要结局
- Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback(Day 0 (Intra-surgery))
- Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback(Day 0 (Intra-surgery))
- Number of Study Devices Replaced During Surgery(Day 0 (Intra-surgery))