Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-30
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Lexington Medical Inc.
INDUSTRY
Responsible Party
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Locations
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Gijos Clinic
Kaunas, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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Antanas Mickevicius
Role: primary
Other Identifiers
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Endostapler05
Identifier Type: -
Identifier Source: org_study_id
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