At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
In Brief
An observational study evaluating AEON Endostapler and Echelon Flex Powered Stapler for Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale. Completed, enrolled 60 participants across 3 sites.
Detailed Summary
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ 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.
Study Details
Timeline
Interventions
Surgery with AEON Endostapler
Surgery with Echelon Flex Powered Stapler