Endostapler Hemostasis Study

Study Overview
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Brief Summary
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The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.

Official Title
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Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler

Conditions
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Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale

Intervention / Treatment
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* Device: AEON Endostapler
* Device: Echelon Flex Powered Stapler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form Informed consent for study obtained and signed from each subject Exclusion Criteria: Planned open surgical approach Prior bariatric operation (i.e. revisional bariatric surgery) Use of staple line reinforcement material (buttress) Patients taking anticoagulants Patients under the age of 18 on the date of the surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AEON Endostapler<br>Stapling performed by AEON Endostapler | Device: AEON Endostapler<br>* Surgery with AEON Endostapler<br>|
| Echelon Flex Powered Stapler<br>Stapling performed by Echelon Flex Powered Stapler | Device: Echelon Flex Powered Stapler<br>* Surgery with Echelon Flex Powered Stapler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staple Line Bleeding | Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding) | 10 seconds after last staple line | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staple Line Leaking | Incidence of postoperative leakage during one-month monitoring period following procedure | 1 month following procedure | 
| Adverse Events | Incidence of reported device-related adverse events | 1 month following procedure | 
| Product Malfunction | Incidence of product malfunction during procedure | During surgery | 
| Blood Transfusion | Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time | Within 72 hours of surgery start | 
| Pain Level | Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain. | 1 week following procedure |