Clinical trial NCT05519215: A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
Official title: A Multi-Center Evaluation of the ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Sleeve Gastrectomy (LSG)
Thoracic Lung Resection Procedure
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2022-08-29
Enrollment: 244
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants with Select Device-related Serious Adverse Events (SAEs)
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Number of Participants with All Device-related, Procedure-related Adverse Events (AEs)
timeFrame: 30 days post-procedure
measure: Number of Participants with All Device-related, Procedure-related SAEs
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory Cardiothoracic Surgery
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Health Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: San Antonio
country: United States
facility: Bariatric Medical Institute of Texas
state: Texas
Study officials:
affiliation: Ethicon Endo-Surgery
name: Ethicon Endo-Surgery Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.