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Recruiting

NCT Number: NCT06474637

Powered Handle Primary Sleeve Gastrectomy Study

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.

Recruiting

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Key information

Conditions

Sleeve Gastrectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gijos Clinic

Kaunas, Lithuania

Location status: Recruiting

Location contact

Antanas Mickevicius

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be within the range of 18-65 years of age
  • Patients undergoing primary sleeve gastrectomy procedures
  • Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.

Exclusion criteria

  • Prior bariatric surgery procedure
  • Sleeve gastrectomy procedure that is planned to be performed via open approach
  • Patients receiving anticoagulant medication(s)
  • Severe heart disease or lung problems
  • Known sensitivity to implant materials
  • Evidence of active (systemic or localized) infection at time of surgery
  • Women who are pregnant or planning to get pregnant in the next 12 months
  • Recent history of known alcohol and/or narcotic abuse
  • Investigational drug or device use within 30 days
  • Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study

Treatment and study plan

AEON Endoscopic Powered Stapler Handle and Reload

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antanas Mickevicius

CONTACT

[email protected]

+37069879074

Sponsors and collaborators

Lead sponsor

Lexington Medical Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 25, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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