Summary
The purpose of this study is to collect clinical safety data on a surgical stapling device called the ECHELON 3000 Stapler. The device is used in patients who are undergoing an operation to remove a part of the stomach or lung (sleeve gastrectomy or lung resection procedure). Participants will be asked to provide information about their medications, medical history, and demographics. The U.S. Food and Drug Administration (FDA) has approved the ECHELON 3000 Stapler as it is being used in this study.
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
Study Location(s)
Beverly
More about this Clinical Trial
Full Title
A Multi-Center Evaluation of the ECHELON? 3000 in General Abdominal and Thoracic Lung Resection Procedures