New surgical stapler shows promise in stomach and lung operations
NCT ID NCT05519215
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
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244 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Jan 2025
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Ascension Providence Hospital
Southfield, Michigan, 48075, United States
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Bariatric Medical Institute of Texas
San Antonio, Texas, 78258, United States
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Emory Cardiothoracic Surgery
Atlanta, Georgia, 30322, United States
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George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
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Henry Ford Health Center
Detroit, Michigan, 48202, United States
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Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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