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Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Gijos Clinic
Kaunas, Lithuania
Start Date
January 30, 2024
Primary Completion Date
December 1, 2027
Completion Date
March 1, 2028
Last Updated
January 14, 2026
100
ESTIMATED participants
AEON Endoscopic Powered Stapler Handle and Reload
DEVICE
Lead Sponsor
Lexington Medical Inc.
NCT07230769
NCT06868992
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06515691