Safety and Efficacy Study of Duet TRS

A Prospective, Single-Center Investigation of the Safety and Performance of the ENDO GIA Staplers With ENDO GIA Single Use Loading Units With DUET TRS TM in a Gastric Bypass Procedure

The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.

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 comorbidities
• 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
• The patient has a history of liver disease
• The patient has a history of drug or alcohol abuse
• The patient has a history of venous thrombosis or pulmonary embolism
• The patient has a history of coagulopathy