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

NCT05519215 | Completed FDA Device

• 1 other identifier: ESC202103
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Laparoscopic Sleeve Gastrectomy (LSG); Thoracic Lung Resection Procedure

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days post procedure

Secondary Outcomes (2)

• Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)

  30 days post-procedure

• Number of Participants with All Device-related, Procedure-related SAEs

  30 days post-procedure

Study Arms (1)

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

Interventions

ECHELON 3000 Stapler DEVICE

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.

ECHELON 3000 Stapler

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (8)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

George Washington University Hospital

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

Location

Emory Cardiothoracic Surgery

Atlanta, Georgia, 30322, United States

Location

Henry Ford Health Center

Detroit, Michigan, 48202, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Bariatric Medical Institute of Texas

San Antonio, Texas, 78258, United States

Location

Related Publications (2)

• 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.

  PMID: 27162678 BACKGROUND

• Fegelman 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.

  PMID: 27991838 BACKGROUND

Study Officials

• Ethicon Endo-Surgery Clinical Trial

  Ethicon Endo-Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: March 22, 2023
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (8)