The IGBallon (R) - for Use in the Treatment of Obesity

The study will be divided into a screening phase and treatment period. Informed consent must be obtained prior to conducting any screening or other study-related procedures or evaluations. The screening phase will take place 28 days prior to the administration/ingestion of the first device. Participants will be evaluated against the protocol-specific inclusion and exclusion criteria to determine their eligibility for participation in the study. An initial five (5) participants meeting eligibility requirements will ingest a single IGBalloon, undergo an immediate endoscopy to assess device inflation and initial condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6, and 8 weeks. At the 2 week follow-up appointment, a second IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety. At the 4 week follow-up appointment, again, an additional IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety. At the 6 week follow-up appointment, an additional IGBalloon may be ingested if there is still no decrease in weight and/or increase in satiety. At the 8 week follow-up, an additional device (maximum of 5) for the same reasons mentioned above. The initial 5 sentinel patients will undergo an endoscopy to observe balloon inflation and condition of the gastric mucosa. No more than five (5) IGBalloons may be ingested by a single participant. In the event that no significant changes have occurred to the gastric mucosa and no other unanticipated serious adverse events have occurred in the initial five participants, a further 15 participants will begin the treatment and follow-up regimen. This larger cohort of participants will not undergo the endoscopy procedure at the 8 week follow-up but follow the same treatment and follow-up regimen in all other aspects. Further follow-up consultations will occur at 12, 16, 20, 24 and 36 weeks following the ingestion of the first IGBalloon. A final 52-week follow-up will include an additional endoscopy procedure on all participants. Following the 52 week follow-up of all participants, the study will be deemed to have been completed. Participants may elect to keep the IGBalloons in place, or have them removed at the 52 week endoscopy procedure. Those participants electing to keep the balloons in place will be monitored on an ongoing basis. Should participants require follow-up for adverse events or require any additional clinical laboratory or physical examinations, they may return to the clinic as deemed appropriate by the physician.