“Endostapler Hemostasis Study Protocol”
The goal of this prospective, multi-center, post-market study is to measure AEONa"c Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flexa"c Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
Device - AEON Endostapler
Surgery with AEON Endostapler
Device - Echelon Flex Powered Stapler
Surgery with Echelon Flex Powered Stapler
Endostapler Hemostasis Study Protocol