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Clinical Trial Summary

The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.


Clinical Trial Description

Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04712526
Study type Observational
Source Lexington Medical Inc.
Contact
Status Withdrawn
Phase
Start date January 18, 2021
Completion date December 2023

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