Powered Handle Primary Sleeve Gastrectomy Study

Launched by LEXINGTON MEDICAL INC. · Jun 20, 2024

Keywords

ClinConnect Summary

The Powered Handle Primary Sleeve Gastrectomy Study is a clinical trial looking at a specific type of weight loss surgery called sleeve gastrectomy. This study is focused on patients who will have this surgery using a new device called the AEON Endoscopic Powered Handle Stapler. The main goal is to see how many patients experience problems after the surgery, such as bleeding or leaks from the stapled area, which may require extra medical treatment like a blood transfusion or another surgery.

To participate, individuals must be between 18 and 65 years old and be undergoing their first sleeve gastrectomy. They should be physically and mentally ready to follow the study's guidelines and attend follow-up appointments. However, people with certain health issues, like severe heart or lung problems, or those who have had prior weight loss surgeries, are not eligible. If you join this study, you can expect close monitoring after your surgery to ensure your safety and well-being as researchers gather important data on the use of this new surgical tool.

Gender

ALL

Eligibility 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