* Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
* Subjects will be implanted with the EndoPass device for up to 36 months.
* Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
* Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
* All subjects will be followed for 12 months after device removal.
* A single device renewal may take place as needed after the initial implant.
* Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.
