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New surgical stapler shows promise in stomach and lung operations

NCT ID NCT05519215

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new powered stapler (ECHELON 3000) in 244 people having either stomach reduction surgery or lung surgery. The goal was to see if the stapler is safe and works well. Researchers tracked serious problems like infection, bleeding, or air leaks after surgery.

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.

Participants

244 people

The number who actually took part.

Started

Mar 2023

Finished

Jan 2025

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.

Who is studied

Participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure will be included.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Adult and pediatric participants satisfying the following criteria will be considered eligible for enrollment in this study (procedures may be performed with or without a robot): Primary procedure where the ECHELON 3000 Stapler and reload system is planned to be used for tissue transection per the instructions for use (IFU) in either of the following, a) Laparoscopic Sleeve Gastrectomy; b) Lung resection procedures (VATS or open) * Adult participants- Willingness to give consent and comply with all study-related evaluations and visit schedule * Pediatric participants- The participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide documented informed consent for the participants. In addition, assent must be obtained from pediatric participant who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric participant is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's documented informed consent for the participant will be acceptable for the participant to be included in the study Exclusion Criteria: * Physical or psychological condition which would impair study participation * Procedure is a revision/reoperation for the same indication or same anatomical location * A procedure where surgical stapling is contraindicated * Concurrent treatment with medications that the investigator deems could have influence on wound healing * 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ascension Providence Hospital

    Southfield, Michigan, 48075, United States

  • Bariatric Medical Institute of Texas

    San Antonio, Texas, 78258, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Emory Cardiothoracic Surgery

    Atlanta, Georgia, 30322, United States

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037, United States

  • Henry Ford Health Center

    Detroit, Michigan, 48202, United States

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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