A Study of ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-011435
NCT ID: NCT05519215
Sponsor Protocol Number: ESC202103
About this study
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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Adult and pediatric populations satisfying the following criteria will be considered eligible for enrollment in this study:
- Primary procedure where the ECHELON™ 3000 Stapler and reload system is planned to be used for tissue transection per the IFU (with or without the use of a robot) in the following:
- Laparoscopic Sleeve Gastrectomy procedure;
- Lung resection procedure (VATS or open).
- Willingness to give consent and comply with all study-related evaluations and visit schedule.
Exclusion Criteria:
Subjects meeting any of the following criteria (preoperatively) will be considered ineligible for enrollment in this study:
- 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/2/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Todd Kellogg, M.D. |
Closed for enrollment |
|
More information
Publications
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Transection of gastric tissue during laparoscopic sleeve gastrectomy (LSG) can be challenging. Reinforcing the staple line may decrease the incidence of issues requiring intervention.
Read More on PubMed
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Lung cancer is one of the most prevalent malignancies worldwide. The number of anatomic lung cancer resections performed via video-assisted thoracoscopic surgery (VATS) is growing rapidly. Staplers are widely used in VATS procedures, but there is limited clinical data regarding how they might affect performance and postoperative outcomes, including air leak. This clinical trial assessed the use of a powered stapler in VATS lung resection, with a primary study endpoint being occurrence and duration of air leak and prolonged air leak (PAL).
Read More on PubMed