Endostapler Hemostasis Study

Completed

Conditions studied: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale

In brief

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.

Key facts

Study ID

NCT04149925

Run by

Lexington Medical Inc.

People needed

60

Starts

2019-10-22

Expected to finish

2020-02-14

Last updated by the study team

2021-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Planned open surgical approach
• Prior bariatric operation (i.e. revisional bariatric surgery)
• Use of staple line reinforcement material (buttress)
• Patients taking anticoagulants
• Patients under the age of 18 on the date of the surgery

Where it is running

• Avala Hospital — Covington, Louisiana, United States
• Crescent City Surgical Centre — Metairie, Louisiana, United States
• Southern Surgical Hospital — Slidell, Louisiana, United States

Full record on ClinicalTrials.gov

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