A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures

Starting soon · Not applicable

Conditions studied: Surgical Procedures, Operative

In brief

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.

Key facts

Study ID

NCT07744568

Run by

Ethicon Endo-Surgery

People needed

300

Starts

2026-09-16

Expected to finish

2028-02-28

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidate for a gastric procedure (sleeve gastrectomy) where a surgical stapler is intended to be used on the stomach; or candidate for a thoracic procedure (lung resection; only lobectomy, segmentectomy or wedge) where a surgical stapler is intended to be used on the lung
• Willingness to give consent and comply with all study-related evaluations and visit schedule
• At least 18 years of age

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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