Evaluating a new stapler for sleeve gastrectomy procedures
Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Lexington Medical Inc. Industry-sponsored |
| Locations | 1 site (Kaunas) |
| Trial ID | NCT06474637 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who are scheduled for primary sleeve gastrectomy and can comply with post-operative care.
Not a fit: Patients with prior bariatric surgery, severe heart or lung conditions, or those on anticoagulants may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kaunas
- Gijos Clinic — Kaunas, Lithuania (Recruiting)
Study contacts
- Study coordinator: Antanas Mickevicius
- Email: a_mickevicius@yahoo.com
- Phone: +37069879074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.