Stapler Post-market Observational Study

Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.

The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Inclusion Criteria:

• Age at study entry is at least 18 years.
• Patient must sign and date the informed consent form prior to the index-procedure.
• Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
• Patient has a BMI ≥ 40 kg/m.

Exclusion Criteria:

• Patient is pregnant.
• History of bariatric surgery.
• Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.