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

Last updated: February 7, 2025
Sponsor: Ethicon Endo-Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Occlusions

Cardiovascular Disease

Treatment

ECHELON 3000 Stapler

Clinical Study ID

NCT05519215
ESC202103
ESC202103
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult and pediatric participants satisfying the following criteria will beconsidered eligible for enrollment in this study (procedures may be performed withor without a robot): Primary procedure where the ECHELON 3000 Stapler and reloadsystem is planned to be used for tissue transection per the instructions for use (IFU) in either of the following, a) Laparoscopic Sleeve Gastrectomy; b) Lungresection procedures (VATS or open)

  • Adult participants- Willingness to give consent and comply with all study-relatedevaluations and visit schedule

  • Pediatric participants- The participant's parent/legal guardian must be willing togive permission for the participant to participate in the study and providedocumented informed consent for the participants. In addition, assent must beobtained from pediatric participant who possess the intellectual and emotionalability to comprehend the concepts involved in the study. If the pediatricparticipant is not able to provide assent (due to age, maturity and/or inability tointellectually and/or emotionally comprehend the study), the parent/legal guardian'sdocumented informed consent for the participant will be acceptable for theparticipant to be included in the study

Exclusion

Exclusion Criteria:

  • Physical or psychological condition which would impair study participation

  • Procedure is a revision/reoperation for the same indication or same anatomicallocation

  • A procedure where surgical stapling is contraindicated

  • Concurrent treatment with medications that the investigator deems could haveinfluence on wound healing

  • Enrollment in a concurrent interventional clinical study that could impact the studyendpoints

Study Design

Total Participants: 244
Treatment Group(s): 1
Primary Treatment: ECHELON 3000 Stapler
Phase:
Study Start date:
March 22, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • Boca Raton Regional Hospital

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Emory Cardiothoracic Surgery

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Henry Ford Health Center

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Ascension Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Bariatric Medical Institute of Texas

    San Antonio, Texas 78258
    United States

    Active - Recruiting

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