Can a smarter stapler reduce surgical leaks and bleeding?

NCT ID NCT07744568

Not yet recruiting Disease control Sponsor: Ethicon Endo-Surgery Source: ClinicalTrials.gov ↗

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial is testing whether the ETHICON 4000 stapler system works better than standard staplers during stomach and lung surgeries. The study will compare how often air leaks and bleeding occur along the staple line, as well as side effects within 30 days after surgery. About 300 adults having gastric sleeve or lung resection procedures will be randomly assigned to receive either the ETHICON 4000 or a standard stapler. The goal is to see if this new device can improve surgical outcomes.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ETHICON™ 4000 Stapler System (a surgical stapler device)
What this could lead to: If successful, this could lead to safer stomach and lung surgeries with fewer complications like air leaks and bleeding, potentially improving patient recovery.
What could go wrong: This is a post-market study, meaning the device is already available. Results may not show a significant advantage over standard staplers, and individual outcomes can vary based on surgical technique and patient factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SURGICAL PROCEDURES, OPERATIVE

Contacts and locations

Locations

Allegheny General Hospital of Research

Pittsburgh, Pennsylvania, 15212, United States
Cedars Sinai Health Sciences University

Los Angeles, California, 90048, United States
Franciscan Saint Francis Hospital

Indianapolis, Indiana, 46143, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
University of Missouri

Columbia, Missouri, 65212, United States
Washington University School Of Medicine

St Louis, Missouri, 63110, United States

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