Powered Handle Primary Sleeve Gastrectomy Study

Not Applicable

Recruiting

• Conditions: Sleeve Gastrectomy
• Interventions: Device: AEON Endoscopic Powered Stapler Handle and Reload

• Registration Number: NCT06474637
• Lead Sponsor: Lexington Medical Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	AEON Endoscopic Powered Stapler Handle and Reload	-

Primary Outcome Measures

Name	Time	Method
Post Operative Staple Line Complications	1 week	The primary measure of effectiveness and safety will be determined by the incidence of post-operative staple line complications defined as requiring blood transfusion and revision surgery to treat staple line complications.

Secondary Outcome Measures

Name	Time	Method
36-Item Short Form Health Survey (SF-36)	3 weeks	SF-36 scores will be collected at baseline and at the 3-week follow up appointment and compared for quality-of-life changes.
Hospital Stay	1 week	Average hospital stay will be measure and compared in patients without post-operative staple line complications vs. patients with post-operative staple line complications.

Trial Locations

Locations (1)

Gijos Clinic; 🇱🇹 Kaunas, Lithuania