This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity. The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, Pose 2 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). Efficacy will be evaluated based on changes in weight loss for all subjects through 12 months. Adverse events will be recorded throughout the duration of the study.
This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity.