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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05519215
Recruitment Status : Recruiting
First Posted : August 29, 2022
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Description
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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).

Condition or disease Intervention/treatment
Laparoscopic Sleeve Gastrectomy (LSG) Thoracic Lung Resection Procedure Device: ECHELON 3000 Stapler

Study Design
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Study Type : Observational
Estimated Enrollment : 244 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Evaluation of the ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
Actual Study Start Date : March 22, 2023
Estimated Primary Completion Date : April 8, 2024
Estimated Study Completion Date : September 5, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 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. The device-related SAEs that will be captured are infection, bleeding, gastric leak (laparoscopic sleeve gastrectomy [LSG] only), and postoperative air leak (lung resection only).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519215


Contacts
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Contact: Study Contact (513)337-3055 ESC202103@its.jnj.com

Locations
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United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
United States, District of Columbia
George Washington University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20037
United States, Georgia
Emory Cardiothoracic Surgery Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Michigan
Henry Ford Health Center Not yet recruiting
Detroit, Michigan, United States, 48202
Ascension Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
United States, New York
Long Island Jewish Medical Center Not yet recruiting
New Hyde Park, New York, United States, 11040
United States, Texas
Bariatric Medical Institute of Texas Recruiting
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
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Study Director: Ethicon Endo-Surgery Clinical Trial Ethicon Endo-Surgery
More Information
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Publications:

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Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT05519215    
Other Study ID Numbers: ESC202103
ESC202103 ( Other Identifier: Ethicon, Inc. )
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Aortic Dissection
Dissection, Blood Vessel
Aneurysm
Vascular Diseases
 Cardiovascular Diseases
Acute Aortic Syndrome
Aortic Diseases