Endostapler Hemostasis Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-22

Study Completion Date

2020-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AEON Endostapler

Stapling performed by AEON Endostapler

AEON Endostapler

Intervention Type DEVICE

Surgery with AEON Endostapler

Echelon Flex Powered Stapler

Stapling performed by Echelon Flex Powered Stapler

Echelon Flex Powered Stapler

Intervention Type DEVICE

Surgery with Echelon Flex Powered Stapler

Interventions

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AEON Endostapler

Surgery with AEON Endostapler

Intervention Type DEVICE

Echelon Flex Powered Stapler

Surgery with Echelon Flex Powered Stapler

Intervention Type DEVICE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes