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Adjustable intragastric balloon for treatment of obesity: A multicenter, open-label, randomized clinical trial

The Lancet Dec 02, 2021

Dayyeh BKA, Maselli DB, Rapaka B, et al. - This prospective, multicenter, open-label, randomized clinical trial was conducted with the aim to evaluate the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity.

  • At seven US sites, researchers randomly assigned a total of 288 adults aged 22–65 years with obesity to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks.

  • A total of 171 (92%) patients in the aIGB group showed a clinical response.

  • For weight loss plateau or intolerance, 145 (80%) patients had adjustments to the aIGB.

  • An additional mean 5·2% (4·5–5·8) total body weight loss was attained when an upward volume adjustment was done.

  • Downward volume adjustment allowed completion of the full duration of therapy in 21 (75%) patients in the aIGB group.

  • Overall, there appeared a significant weight loss among participants randomized to aIGB with lifestyle intervention, which remained maintained for 6 months following aIGB removal.

  • Maximization of weight loss and tolerance was attained because of individualized therapy permitted by balloon volume adjustability.

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