Adjustable intragastric balloon for treatment of obesity: A multicenter, open-label, randomized clinical trial
The Lancet Nov 19, 2021
Dayyeh BKA, Maselli DB, Rapaka B, et al. - This multicenter, open-label, randomized clinical trial was performed to establish the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity.
A total of 288 patients were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks.
At 32 weeks, the aIGB group vs the control group had mean total bodyweight loss of 15·0% vs 3·3%, respectively.
Overall outcomes revealed achievement of significant weight loss when aIGB was combined with lifestyle modification; the weight loss remained maintained for 6 months following removal.
Individualized therapy permitted by the balloon volume adjustability aided in maximizing weight loss and tolerance.
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