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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-22

Study Completion Date

2025-01-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Laparoscopic Sleeve Gastrectomy (LSG) Thoracic Lung Resection Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

ECHELON 3000 Stapler

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No