Evaluating a new stapler for sleeve gastrectomy procedures
Official title: Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Run by Lexington Medical Inc. · NCT06474637 · Data updated 2026-11-12
This study is testing a new stapler used in weight loss surgery to see if it helps prevent problems like bleeding or leaks after the procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Lexington Medical Inc. Industry-sponsored |
| Locations | 1 site (Kaunas) |
| Status | Recruiting |
| Started | January 30, 2024 |
| Main results expected | December 2027 |
| Study ends | March 2028 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT06474637 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 who are scheduled for primary sleeve gastrectomy and can comply with post-operative care.
✕Probably not a fit
Patients with prior bariatric surgery, severe heart or lung conditions, or those on anticoagulants may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and effectiveness of the AEON Endoscopic Powered Handle Stapler in patients undergoing primary sleeve gastrectomy. It is a prospective, single-arm, single-center study focusing on the incidence of post-operative complications related to the staple line, such as bleeding or leaks. The primary endpoint is to determine the percentage of patients who experience these complications requiring further medical intervention. The study will involve close monitoring of patients post-surgery to evaluate outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing sleeve gastrectomy.
How similar studies have gone: While the use of powered staplers in surgical procedures is common, this specific approach is novel and has not been extensively tested in the context of sleeve gastrectomy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be within the range of 18-65 years of age 2. Patients undergoing primary sleeve gastrectomy procedures 3. Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule. Exclusion Criteria: 1. Prior bariatric surgery procedure 2. Sleeve gastrectomy procedure that is planned to be performed via open approach 3. Patients receiving anticoagulant medication(s) 4. Severe heart disease or lung problems 5. Known sensitivity to implant materials 6. Evidence of active (systemic or localized) infection at time of surgery 7. Women who are pregnant or planning to get pregnant in the next 12 months 8. Recent history of known alcohol and/or narcotic abuse 9. Investigational drug or device use within 30 days 10. Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study
Where it's running
-
Gijos Clinic
Kaunas, Lithuania Recruiting
Study contacts
- Study coordinator: Antanas Mickevicius
- Email: a_mickevicius@yahoo.com
- Phone: +37069879074
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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15-year outcomes after sleeve gastrectomy in France
This study looks at how people who had sleeve gastrectomy have fared over 15 years to see long-term weight changes and health effects.
-
Extra daily iron after sleeve gastrectomy to prevent anemia
This study tests whether taking an extra daily iron pill plus a multivitamin prevents iron deficiency anemia in adults during the six months after sleeve gastrectomy compared with taking a multivitamin alone.
-
Foot reflexology to reduce nausea after sleeve gastrectomy
This will try foot reflexology to see if it reduces nausea and vomiting in adults after sleeve gastrectomy.
-
Digestion and gut function after bariatric surgery
This project will test how digestion — including enzymes, bile acids, pH, and transit time — works in adults with obesity and in people at least one year after Roux‑en‑Y or sleeve gastrectomy by collecting intestinal samples and using a swallowable sensor capsule.
-
Vestibular and balance changes before and after sleeve gastrectomy
This study will see if vestibular (balance) function improves in adults having sleeve gastrectomy for severe obesity by testing them before surgery and at one and six months after surgery.
-
Link between MASH and mitochondrial membrane changes in people having bariatric surgery.
We will test whether changes in mitochondria-associated membranes (MAMs) in liver cells and blood immune cells are linked to MASH in adults undergoing bariatric surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.