A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
2026年9月1日 更新者：Ethicon Endo-Surgery
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
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.
研究概览
研究类型
介入性
注册 (估计的)
300
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kari Loing
- 电话号码：(513) 337-7000
- 邮箱：RA-ESC202408@its.jnj.com
学习地点
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California
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Los Angeles、California、美国、90048
- Cedars Sinai Health Sciences University
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Indiana
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Indianapolis、Indiana、美国、46143
- Franciscan Saint Francis Hospital
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Missouri
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Columbia、Missouri、美国、65212
- University of Missouri
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St Louis、Missouri、美国、63110
- Washington University School of Medicine
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital of Research
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion criteria:
- 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
Exclusion criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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).
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The Investigator will choose a commercially available stapler and reload(s) per their professional preference produced by any manufacturer and aligned with the manufacturer's IFU.
The only exception is that the Investigator may not use the ETHICON™ 4000 Stapler System.
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实验性的：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.
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The Investigator will use the ETHICON™ 4000 Stapler System, as per instructions for use (IFU).
This system is composed of two primary components: The ETHICON 4000 Stapler and the ETHICON 3D Reloads.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line
大体时间：Intraoperative
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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.
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Intraoperative
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Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line
大体时间：Intraoperative
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Percentage of firings associated with intraoperative air leak at the staple line (prior to prophylactic or intervention to the staple line) will be reported.
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Intraoperative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Length of Hospital Stay
大体时间：Up to 30 Days Post Procedure
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Number of days from the date of hospital admission to discharge from the hospital will be reported.
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Up to 30 Days Post Procedure
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Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure
大体时间：Up to 30 Days Post Procedure
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Percentage of participants experiencing gastric leak occurring up to 30 days post procedure will be reported.
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Up to 30 Days Post Procedure
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Thoracic: Duration of Tube Placement
大体时间：Up to 30 Days Post Procedure
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Duration of chest tube placement and removal will be reported.
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Up to 30 Days Post Procedure
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Thoracic: Postoperative Air Leak Duration
大体时间：Up to 30 Days Post Procedure
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Postoperative air leak duration upon submersion test (prior to prophylactic or intervention to the staple line) using a binary determination (air leak, yes/no) will be reported.
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Up to 30 Days Post Procedure
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Thoracic: Percentage of Participants with Prolonged Air Leak (PAL)
大体时间：Up to 30 Days Post Procedure
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PAL is defined as an air leak that persists more than (>) 5 days after the study procedure.
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Up to 30 Days Post Procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Gianluca Casali, MD、Ethicon Endo-Surgery
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月16日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年2月28日
研究注册日期
首次提交
2026年7月30日
首先提交符合 QC 标准的
2026年7月30日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ESC202408
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data sharing policy of Johnson & Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.