Laparoscopic Sleeve Gastrectomy (LSG)NCT05519215
A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
An observational study of Laparoscopic Sleeve Gastrectomy (LSG) and Thoracic Lung Resection Procedure, run by Ethicon Endo-Surgery at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy (LSG), Thoracic Lung Resection Procedure
- What is being tested?
- ECHELON 3000 Stapler
- Type of treatment
- Medical device
- How many people
- 244 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Mar 2023to 8 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure will be included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory Cardiothoracic Surgery
Atlanta, Georgia, 30322
Henry Ford Health Center
Detroit, Michigan, 48202
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Mayo Clinic
Rochester, Minnesota, 55905
Bariatric Medical Institute of Texas
San Antonio, Texas, 78258
Ascension Providence Hospital
Southfield, Michigan, 48075
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: 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).
- Being tested
- ECHELON 3000 Stapler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHELON 3000 StaplerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: ECHELON 3000 Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Select Device-related Serious Adverse Events (SAEs)
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).
Measured: 30 days post procedure
Secondary outcomes (2)
Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)
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.
Measured: 30 days post-procedure
Number of Participants with All Device-related, Procedure-related SAEs
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.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start22 Mar 2023
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Sleeve Gastrectomy (LSG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ethicon Endo-Surgery Clinical Trial, Study director, Ethicon Endo-Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519215
- Sponsor's protocol ID
- ESC202103
- Other IDs
- ESC202103
- Status last verified
- Jan 2026
- First submitted
- 25 Aug 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Qiu B, Yan W, Chen K, Fu X, Hu J, Gao S, Knippenberg S, Schwiers M, Kassis E, Yang T. A multi-center evaluation of a powered surgical stapler in video-assisted thoracoscopic lung resection procedures in China. J Thorac Dis. 2016 May;8(5):1007-13. doi: 10.21037/jtd.2016.03.88.
PubMed 27162678Fegelman E, Knippenberg S, Schwiers M, Stefanidis D, Gersin KS, Scott JD, Fernandez AZ. Evaluation of a Powered Stapler System with Gripping Surface Technology on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):489-494. doi: 10.1089/lap.2016.0513. Epub 2016 Dec 19.
PubMed 27991838
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Evaluation of the ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
- ClinicalTrials.gov ID
- NCT05519215
- Acronym / sponsor ID
- ESC202103
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECHELON 3000 Stapler | – | Device: ECHELON 3000 StaplerThis 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure will be included.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHELON 3000 StaplerThere 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. | Device | ECHELON 3000 Stapler |
Primary outcome
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).
2 secondary outcomes
Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)
Time frame: 30 days post-procedure
Number of Participants with All Device-related, Procedure-related SAEs
Time frame: 30 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 27162678Qiu B, Yan W, Chen K, Fu X, Hu J, Gao S, Knippenberg S, Schwiers M, Kassis E, Yang T. A multi-center evaluation of a powered surgical stapler in video-assisted thoracoscopic lung resection procedures in China. J Thorac Dis. 2016 May;8(5):1007-13. doi: 10.21037/jtd.2016.03.88.
- Background: PubMed 27991838Fegelman E, Knippenberg S, Schwiers M, Stefanidis D, Gersin KS, Scott JD, Fernandez AZ. Evaluation of a Powered Stapler System with Gripping Surface Technology on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):489-494. doi: 10.1089/lap.2016.0513. Epub 2016 Dec 19.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethicon Endo-Surgery Clinical Trial study director
Ethicon Endo-Surgery
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Sleeve Gastrectomy (LSG) and Thoracic Lung Resection Procedure, run by Ethicon Endo-Surgery at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Select Device-related Serious Adverse Events (SAEs) (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519215, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.