A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures

January 8, 2026 updated by: Ethicon Endo-Surgery

A Multi-Center Evaluation of the ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures

The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (Video-Assisted Thoracoscopic [ATS] or open approach).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Cardiothoracic Surgery
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Center
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
    • Texas
      • San Antonio, Texas, United States, 78258
        • Bariatric Medical Institute of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECHELON 3000 Stapler
This prospective study will include the participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure and collect clinical data in a post-market setting. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON 3000 Stapler and reloads instructions for use (IFU).
Device: ECHELON 3000 Stapler
There is no intervention, beyond necessary clinical care, in this study. Echelon 3000 Stapler is used for transection and resection in LSG or lung surgical procedure per its IFU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Select Device-related Serious Adverse Events (SAEs)
Time Frame: 30 days post procedure
An adverse event (AE) is defined as any untoward medical occurrence, regardless of its relationship to study device or study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of pre-existing condition, which occurs throughout the duration of the clinical study. SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect. The device-related SAEs that will be captured are infection or symptoms of infection, bleeding, gastric leak (laparoscopic sleeve gastrectomy [LSG] only), and postoperative air leak (lung resection only).
30 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)
Time Frame: 30 days post-procedure
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.
30 days post-procedure
Number of Participants with All Device-related, Procedure-related SAEs
Time Frame: 30 days post-procedure
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. A SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or a body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect.
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery

Investigators

  • Study Director: Ethicon Endo-Surgery Clinical Trial, Ethicon Endo-Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Actual)

January 8, 2025

Study Completion (Actual)

January 8, 2025

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESC202103 (Other Identifier: Ethicon, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Laparoscopic Sleeve Gastrectomy (LSG)

Clinical Trials on ECHELON 3000 Stapler

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe