Multi-Center Pre-Bariatric Weight Loss Study

A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss

The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.

Inclusion Criteria:

• BMI > 35 with a significant comorbid condition or BMI 40-60
• Candidate for Bariatric Surgery

Exclusion Criteria:

• No pathologies of the GI Tract
• No anti-coagulant or non-steroidal anti-inflammatory medications