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NCT05519215 · ClinicalTrials.gov registry record
A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
A clinical trial of Laparoscopic Sleeve Gastrectomy (LSG) and Thoracic Lung Resection Procedure, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- 244
- Enrollment target
- 8
- Study locations
NCT05519215: Completed study of Laparoscopic Sleeve Gastrectomy (LSG) and Thoracic Lung Resection Procedure, sponsored by Ethicon Endo-Surgery.
NCT05519215 is a study of Laparoscopic Sleeve Gastrectomy (LSG) and Thoracic Lung Resection Procedure that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 244 participants. The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05519215, a study of Laparoscopic Sleeve Gastrectomy (LSG) and Thoracic Lung Resection Procedure, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- 244 participants
- Enrollment target
- 8
- Study locations
Study 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).
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence, regardless of its relationship to study device or study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of pre-existing condition, which occurs throughout the duration of the clinical study. SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or body function; hospitalization
Conditions Studied
Interventions
- DEVICE ECHELON 3000 Stapler
Study Locations (8)
Michigan
- Henry Ford Health Center - Detroit
- Ascension Providence Hospital - Southfield
California
- Cedars-Sinai Medical Center - Los Angeles
District of Columbia
- George Washington University Hospital - Washington D.C.
Georgia
- Emory Cardiothoracic Surgery - Atlanta
Minnesota
- Mayo Clinic - Rochester
New York
- Long Island Jewish Medical Center - New Hyde Park
Texas
- Bariatric Medical Institute of Texas - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2025-01-08 |
What the finished NCT05519215 record still lists
NCT05519215 is an observational study that tracks outcomes without assigning an intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Laparoscopic Sleeve Gastrectomy (LSG) appearing as the primary indexed condition, and to 1 intervention - of which ECHELON 3000 Stapler is the first listed.
NCT05519215 lists 8 locations in 7 states (Michigan, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05519215 about?
NCT05519215 is a clinical study titled "A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures". 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).
What is the current status of trial NCT05519215?
This trial is currently completed. The enrollment target is 244 participants. The study started on 2023-03-22. Estimated completion is 2025-01-08.
What conditions does trial NCT05519215 study?
This clinical trial studies the following conditions: Laparoscopic Sleeve Gastrectomy (LSG), Thoracic Lung Resection Procedure.
What interventions are being tested in trial NCT05519215?
The interventions under investigation include: ECHELON 3000 Stapler (DEVICE).
Who is sponsoring clinical trial NCT05519215?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05519215 being conducted?
This trial has 8 study locations across California, District of Columbia, Georgia, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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