Endostapler Gastric Bypass Study

Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery

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.

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.

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