Powered Handle Primary Sleeve Gastrectomy Study

Last updated: June 20, 2024
Sponsor: Lexington Medical Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Treatment

AEON Endoscopic Powered Stapler Handle and Reload

Clinical Study ID

NCT06474637
Endostapler05
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thetreating surgeon, to the subject being a poor candidate for the study

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: AEON Endoscopic Powered Stapler Handle and Reload
Phase:
Study Start date:
January 30, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Gijos Clinic

    Kaunas,
    Lithuania

    Active - Recruiting

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