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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEON Endoscopic Powered Stapler Handle and Reload | Device | The AEONâ„¢ 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| 36-Item Short Form Health Survey (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antanas Mickevicius | Contact | +37069879074 | a_mickevicius@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gijos Clinic | Recruiting | Kaunas | Lithuania |
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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 |