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

Ethicon

Status: Enrolling

Conditions: Laparoscopic Sleeve Gastrectomy (LSG); Thoracic Lung Resection Procedure

Treatments: Device: ECHELON 3000 Stapler

Study type: Observational

Funder types: Industry

Identifiers

NCT05519215

ESC202103 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 244 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

244 participants in 1 patient group

ECHELON 3000 Stapler

Description:

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).

Treatment:

Device: ECHELON 3000 Stapler