Actively Recruiting
Powered Handle Primary Sleeve Gastrectomy Study
Led by Lexington Medical Inc. · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Powered Handle Primary Sleeve Gastrectomy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gijos Clinic
Kaunas, Lithuania
Actively Recruiting
Research Team
A
Antanas Mickevicius
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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