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A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Sponsor: Ethicon Endo-Surgery
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-09-16
Completion Date
2028-02-28
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
ETHICON™ 4000 Stapler System
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.
Standard of Care Stapler and Reloads
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.
Locations (6)
Cedars Sinai Health Sciences University
Los Angeles, California, United States
Franciscan Saint Francis Hospital
Indianapolis, Indiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Missouri
Columbia, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Allegheny General Hospital of Research
Pittsburgh, Pennsylvania, United States