NCT06474637

Powered Handle Primary Sleeve Gastrectomy Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lexington Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleeve Gastrectomy

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2024-01-30
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2024-06-25
• Last updated: 2026-01-14

Locations

1 site across 1 country: Lithuania

Regulatory

• FDA-regulated device study