Study of Weight Loss Using Gastric Stimulation in Obese Patients

SHAPE: Screened Health Assessment & Pacer Evaluation

The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.

The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.

SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.

Inclusion Criteria:

• 18 to 65 years of age at time of screening
• BMI of 35 to 55 kg/m2 at time of screening
• Patients with a reported history of five years of obesity (BMI > 30 kg/m2)

Exclusion Criteria:

• Patients who are excluded by the screening algorithm
• Patients scoring 29 or higher on the Binge Eating Scale Questionnaire
• Patients taking any weight loss medication or other drugs that can affect body weight