The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System in a population of patients with a BMI between 35 and 55. Initially, a maximum of 150 patients will be followed for 12 months in a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of the IGS. All patients will be implanted with the IGS System and randomized to a control group (IGS OFF) or a treatment group (IGS ON). Both groups will follow a 500kcal/day-deficit diet (Appendix A) and participate in monthly support group meetings (Appendix E). The study will last for 24 months after randomization. The sponsor plans to submit a PreMarket Approval (PMA) application when all patients have completed 12 months of post-randomization follow-up. After 12 months from randomization, patients will continue to be followed monthly for another year, during which all patients will receive gastric electrical stimulation and the long-term efficacy and safety and maintenance of weight loss will be evaluated. After 24 months from randomization, all remaining patients will have the option to enter an extension study for an additional four years, during which the long-term efficacy and safety and maintenance of weight loss will continue to be evaluated.
The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System in a population of patients with a BMI between 35 and 55.