Health TrialsbyHealthPanel

Powered Handle Primary Sleeve Gastrectomy Study

ConditionSleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLexington Medical Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post Operative Staple Line Complications

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.

Time frame
1 week

Secondary outcomes

1

Hospital Stay

Average hospital stay will be measure and compared in patients without post-operative staple line complications vs. patients with post-operative staple line complications.

Time frame
1 week
2

36-Item Short Form Health Survey (SF-36)

SF-36 scores will be collected at baseline and at the 3-week follow up appointment and compared for quality-of-life changes.

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lexington Medical Inc.

Lead sponsor

Source ClinicalTrials.gov
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