NCT04149925

Endostapler Hemostasis Study

Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Lexington Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale

Interventions

Type	Name	Description
DEVICE	AEON Endostapler	Surgery with AEON Endostapler
DEVICE	Echelon Flex Powered Stapler	Surgery with Echelon Flex Powered Stapler

Timeline

• Start date: 2019-10-22
• Primary completion: 2020-01-24
• Completion: 2020-02-14
• First posted: 2019-11-04
• Last updated: 2021-02-23
• Results posted: 2020-04-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study