Endostapler Sleeve Gastrectomy Study

A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy

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.

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.

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