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New stapler aims to make sleeve gastrectomy safer

NCT ID NCT06474637

Disease control Sponsor: Lexington Medical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new powered stapler (AEON) used during sleeve gastrectomy, a common weight-loss surgery. The goal is to see if it reduces serious complications like bleeding or leaks from the staple line. About 100 adults having their first sleeve gastrectomy will be enrolled and followed for 3 weeks after surgery.

What this could mean

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

Active substance
AEON Endoscopic Powered Stapler Handle and Reload (a surgical stapling device)
What this could lead to
If successful, this stapler could make sleeve gastrectomy surgery safer by reducing serious complications like bleeding or leaks.
What could go wrong
This is a small, early-stage study with no comparison group, so results may not apply to all patients. The device could still fail to reduce complications or cause unexpected issues.

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 100 people

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

Started

Jan 2024

Expected to finish

Mar 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 to 65 years

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: 1. Be within the range of 18-65 years of age 2. Patients undergoing primary sleeve gastrectomy procedures 3. Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule. Exclusion Criteria: 1. Prior bariatric surgery procedure 2. Sleeve gastrectomy procedure that is planned to be performed via open approach 3. Patients receiving anticoagulant medication(s) 4. Severe heart disease or lung problems 5. Known sensitivity to implant materials 6. Evidence of active (systemic or localized) infection at time of surgery 7. Women who are pregnant or planning to get pregnant in the next 12 months 8. Recent history of known alcohol and/or narcotic abuse 9. Investigational drug or device use within 30 days 10. Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study

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Conditions

The condition(s) this trial relates to.

obesity disorder

As listed by the trial registrant

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

Sleeve gastrectomy

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Gijos Clinic

    RECRUITING

    Kaunas, Lithuania

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