Phase
Condition
Chest Pain
Occlusions
Cardiovascular Disease
Treatment
ECHELON 3000 Stapler
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult and pediatric participants satisfying the following criteria will beconsidered eligible for enrollment in this study (procedures may be performed withor without a robot): Primary procedure where the ECHELON 3000 Stapler and reloadsystem is planned to be used for tissue transection per the instructions for use (IFU) in either of the following, a) Laparoscopic Sleeve Gastrectomy; b) Lungresection procedures (VATS or open)
Adult participants- Willingness to give consent and comply with all study-relatedevaluations and visit schedule
Pediatric participants- The participant's parent/legal guardian must be willing togive permission for the participant to participate in the study and providedocumented informed consent for the participants. In addition, assent must beobtained from pediatric participant who possess the intellectual and emotionalability to comprehend the concepts involved in the study. If the pediatricparticipant is not able to provide assent (due to age, maturity and/or inability tointellectually and/or emotionally comprehend the study), the parent/legal guardian'sdocumented informed consent for the participant will be acceptable for theparticipant to be included in the study
Exclusion
Exclusion Criteria:
Physical or psychological condition which would impair study participation
Procedure is a revision/reoperation for the same indication or same anatomicallocation
A procedure where surgical stapling is contraindicated
Concurrent treatment with medications that the investigator deems could haveinfluence on wound healing
Enrollment in a concurrent interventional clinical study that could impact the studyendpoints
Study Design
Connect with a study center
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
George Washington University Hospital
Washington, District of Columbia 20037
United StatesActive - Recruiting
Boca Raton Regional Hospital
Boca Raton, Florida 33486
United StatesSite Not Available
Emory Cardiothoracic Surgery
Atlanta, Georgia 30322
United StatesActive - Recruiting
Henry Ford Health Center
Detroit, Michigan 48202
United StatesActive - Recruiting
Ascension Providence Hospital
Southfield, Michigan 48075
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
University of Missouri
Columbia, Missouri 65212
United StatesSite Not Available
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesActive - Recruiting
Bariatric Medical Institute of Texas
San Antonio, Texas 78258
United StatesActive - Recruiting
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