Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity

Abstract Background Intragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. Methods After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration. Results Our patient population included 26 women and 4 men aged 26–59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively ( P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal. Conclusion In the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile.