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Powered Handle Primary Sleeve Gastrectomy Study

RecruitingNAAges 18 Years - 65 YearsAllLexington Medical Inc.
NCT06474637 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • AEON Endoscopic Powered Stapler Handle and Reload
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Where

1 site
Gijos Clinic
Kaunas, Lithuania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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