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Safety and Efficacy of the SMART Device for Overweight and Obese Adults
The purpose of this study is to demonstrate that (1) we will observe at least 40% of the subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared to Week 0 is ≥4% in the Per Protocol population.
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