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Can a smarter stapler reduce surgical leaks and bleeding?

NCT ID NCT07744568

Disease control Sponsor: Ethicon Endo-Surgery Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Sep 04, 2026 · Updated 3 times

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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