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Powered Handle Primary Sleeve Gastrectomy Study
Sponsor: Lexington Medical Inc.
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.
Official title: Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-01-30
Completion Date
2028-03
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
AEON 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).
Locations (1)
Gijos Clinic
Kaunas, Lithuania