Endostapler Gastric Bypass Study

Study Overview
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Brief Summary
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The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

Detailed Description
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Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB 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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Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery

Conditions
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Obesity

Intervention / Treatment
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* Device: AEON Endostapler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing planned laparoscopic Roux-en-Y gastric bypass 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 PTT > 45sec, or PT> 15sec, or 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of reported device-related adverse events |  | Within 30-day post-operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic staple line bleeding | Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding) | Within surgery | 
| Laparoscopic staple line bleeding | Incidence of intraoperative staple line bleeding from laparoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Laparoscope Images (1: No bleeding, 5: Profuse Bleeding) | Within surgery | 
| Incidence of intraoperative or postoperative blood transfusion |  | Within 72 hours of surgery start time | 
| Incidence of product malfunction |  | Within surgery |