Endostapler Hemostasis Study

Lexington Medical

Status

Completed

Conditions

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

Treatments

Device: Echelon Flex Powered Stapler

Device: AEON Endostapler

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04149925

Endostapler01

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
Informed consent for study obtained and signed from each subject

Exclusion criteria