Tri Staple Technology Stapler Used in Gastric Bypass

A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure

The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.

Inclusion Criteria:

• The patient must be 18-65 years of age.
• The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
• The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria:

• The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
• The patient is pregnant.
• The patient has an active or history of, infection at the operative site.
• The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
• Patient has an abdominal ventral hernia requiring mesh repair
• The patient has a history of clinically significant liver disease
• The patient has a history of drug or alcohol abuse within 2 years of enrollment
• The patient has a history of venous thrombosis or pulmonary embolism
• The patient has a history of coagulopathy