A Post Market, Two-Arm, Multi-Center, Randomized Controlled Trial Comparing Clinical Outcomes Using the ETHICON™ 4000 Stapler System Versus Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line
研究概览
简要总结
The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach surgeries and by evaluating the side effects occurring within 30 days of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Prior to study enrollment, the participant and treating surgeon must have determined to proceed with one of the following surgical procedures as part of routine clinical care: a. A gastric procedure (sleeve gastrectomy) involving stapling of the stomach; or b. A thoracic procedure (lung resection limited to lobectomy, segmentectomy, or wedge resection) involving stapling of the lung
- •Willingness to give consent and comply with all study-related evaluations and visit schedule
- •At least 18 years of age
排除标准
- •Physical or psychological condition which would impair study participation
- •The planned procedure is a revision/ reoperation for the same indication or same anatomical location
- •Trauma participants
- •Any condition or clinically significant finding that, in the Investigator's judgement, may interfere with study participation, impact the assessment of endpoints, or compromise the patient's safety or welfare
- •Any medical condition that the Investigator deems could impact inflammatory or immune response
- •Enrollment in a concurrent interventional clinical study that could impact the study endpoints
研究组 & 干预措施
Standard of Care Stapler System
Eligible participants for a gastric or thoracic surgery randomized to the standard of care arm will undergo the surgical procedure with a standard of care stapler and reloads, as per instructions for use (IFU).
干预措施: Standard of Care Stapler and Reloads (Device)
ETHICON 4000 Stapler System
Eligible participants for a gastric or thoracic surgery randomized to the ETHICON 4000 arm will undergo the surgical procedure with the ETHICON 4000 Stapler System, as per IFU.
干预措施: ETHICON™ 4000 Stapler System (Device)
结局指标
主要结局
Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line
时间窗: Intraoperative
Percentage of firings associated with each intraoperative grade of bleeding at the staple line (prior to prophylactic or intervention to the staple line) will be reported. The percentage of staple firings for each bleeding grade and for bleeding scores of 4 or below, 3 or below, 2 or below, 1 or below, and 0 will be estimated.
Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line
时间窗: Intraoperative
Percentage of firings associated with intraoperative air leak at the staple line (prior to prophylactic or intervention to the staple line) will be reported.
次要结局
- Length of Hospital Stay(Up to 30 Days Post Procedure)
- Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure(Up to 30 Days Post Procedure)
- Thoracic: Duration of Tube Placement(Up to 30 Days Post Procedure)
- Thoracic: Postoperative Air Leak Duration(Up to 30 Days Post Procedure)
- Percentage of Participants with Prolonged Air Leak (PAL)(Up to 30 Days Post Procedure)
- Thoracic: Percentage of Participants with Prolonged Air Leak (PAL)(Up to 30 Days Post Procedure)