RecruitingNot ApplicableNCT06474637

Powered Handle Primary Sleeve Gastrectomy Study

Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy

Sponsor

Lexington Medical Inc.

Enrollment

100 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

Sleeve Gastrectomy

Summary

The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

Be within the range of 18-65 years of age
Patients undergoing primary sleeve gastrectomy procedures
Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.

Exclusion Criteria10

Prior bariatric surgery procedure
Sleeve gastrectomy procedure that is planned to be performed via open approach
Patients receiving anticoagulant medication(s)
Severe heart disease or lung problems
Known sensitivity to implant materials
Evidence of active (systemic or localized) infection at time of surgery
Women who are pregnant or planning to get pregnant in the next 12 months
Recent history of known alcohol and/or narcotic abuse
Investigational drug or device use within 30 days
Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study

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Interventions

DEVICEAEON Endoscopic Powered Stapler Handle and Reload

The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload (2.0mm, 2.5mm, 3.25mm, 4.0mm, 5.0mm and 5.5mm).