Powered Handle Primary Sleeve Gastrectomy Study

January 13, 2026 updated by: Lexington Medical Inc.

Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Lithuania
      • Kaunas, Lithuania
        • Recruiting
        • Gijos Clinic
        • Contact:
          • Antanas Mickevicius

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Device: AEON Endoscopic Powered Stapler Handle and Reload
The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload (2.0mm, 2.5mm, 3.25mm, 4.0mm, 5.0mm and 5.5mm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Staple Line Complications
Time Frame: 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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Stay
Time Frame: 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.
1 week
36-Item Short Form Health Survey (SF-36)
Time Frame: 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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexington Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Endostapler05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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