Clinical Trial

Endostapler Hemostasis Study Protocol

Study Description

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - AEON Endostapler

Surgery with AEON Endostapler

Device - Echelon Flex Powered Stapler

Surgery with Echelon Flex Powered Stapler

Additional Information

Official Study Title

Endostapler Hemostasis Study Protocol

Clinical Trial ID

NCT04149925

ParticipAid ID

epYM6a