Sleeve Gastrectomy
Conditions
Keywords
LSG (Laparoscopic Sleeve Gastrectomy)
Brief 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.
Interventions
DEVICEAEON 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).
Sponsors
Lexington Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 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 the treating surgeon, to the subject being a poor candidate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Staple Line Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay | 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. |
| 36-Item Short Form Health Survey (SF-36) | 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. |
Countries
Lithuania
Contacts
Primary ContactAntanas Mickevicius
Outcome results
None listed