Actively Recruiting
Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Led by Lexington Medical Inc. · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate patients undergoing primary sleeve gastrectomy procedures using the AEON Endoscopic Powered Stapler Handle and Stapler Reload. The study focuses on assessing post-operative staple line complications such as bleeding or leaks that require blood transfusion or revision surgery. It is a prospective, single-arm, single-center clinical evaluation sponsored by Lexington Medical Inc.
CONDITIONS
Brief Title
Powered Handle Primary Sleeve Gastrectomy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 65 years of age
- 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 planned to be performed via open approach
- Currently receiving anticoagulant medications
- Severe heart disease or lung problems
- Known sensitivity to implant materials
- Active (systemic or localized) infection at time of surgery
- Women who are pregnant or planning pregnancy within 12 months
- Recent history of alcohol and/or narcotic abuse
- Use of investigational drug or device within 30 days
- Any other factors making the participant a poor candidate based on surgeon's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 week
Participants undergo primary sleeve gastrectomy using the AEON Endoscopic Powered Stapler Handle and Reload and receive immediate post-operative care.
1 surgery visit and several post-operative visits during hospital stay
Duration - Up to 3 weeks
Participants are monitored for post-operative staple line complications and recovery, including assessments with the 36-Item Short Form Health Survey (SF-36).
Approximately 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Gijos Clinic
Kaunas, Lithuania
Actively Recruiting
Research Team
A
Antanas Mickevicius
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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