Endostapler Sleeve Gastrectomy Study

Study Overview
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Brief Summary
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The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.

Detailed Description
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Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. 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.

Official Title
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A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy

Conditions
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Obesity

Intervention / Treatment
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* Device: AEON Endostapler
* Device: Endo GIA Reloads with Tri-Staple Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing planned laparoscopic sleeve gastrectomy Informed consent for study obtained and signed from each subject Exclusion Criteria: Planned open surgical approach Use of staple line reinforcement material (buttress) Revision or other bariatric procedure Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or Partial Thromboplastin Time (PTT) >45sec, or Prothrombin Time (PT) >15sec, or International Normalized Ratio (INR) >1.5 Patients with active HIV or Hepatitis B Patients under the age of 18 on the date of the surgery Patients who are pregnant Patients using tobacco products within the last 2 weeks prior to surgery date Patients using cortisone or related products within the last 2 weeks prior to surgery date

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 with AEON Endostapler | Device: AEON Endostapler<br>* Surgery with AEON Endostapler<br>|
| Endo GIA Reloads with Tri-Staple Technology<br>Stapling performed with Endo GIA Reloads with Tri-Staple Technology | Device: Endo GIA Reloads with Tri-Staple Technology<br>* Surgery with Endo GIA Reloads with Tri-Staple Technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Endoscopic Staple Line Bleeding Score | Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. | Within surgery, after the last stapler firing | 
| Intraoperative Laparoscopic Staple Line Bleeding Score | Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. | Within surgery, images captured 10 seconds after the last stapler firing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Leakage Requiring Intervention | Number of participants with postoperative leakage requiring intervention | Within 30-day post-operative period | 
| Number of Participants With Intraoperative or Postoperative Blood Transfusion | Number of participants with intraoperative or postoperative blood transfusion | Within 72 hours of surgery start time | 
| Number of Participants With Reported Device-related Adverse Events | Number of participants with reported device-related adverse events | Within 30-day post-operative period | 
| Number of Participants With Product Malfunction | Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended. | Within surgery |