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A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults with Obesity

All genders
person-wave 22-65
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Principal Investigator: Sajani Shah, MD

Obesity is a chronic, debilitating, multi-factorial disease that has reached worldwide pandemic proportions. The prevalence of obesity has tripled since the 1980s in many countries of the World Health Organization (WHO) European region. The WHO estimates that by 2015, 2.3 billion people will be overweight and over 700 million will be obese. Furthermore, the movement of people into the obese category (Body Mass Index (BMI) > 30) continues to increase by 1% of the population per year2, and the prevalence of the Class III obesity has almost doubled over the last twenty years with an estimated prevalence of 4.7% in 1999-2000 and 9.2% in 2017-2018%.Significant evidence indicates that successful treatment of obesity results in a reduced incidence of co-morbid diseases. Specifically, a 5-10% total weight loss can significantly reduce or prevent coronary heart disease, hyperlipidemia, hypertension, type 2 diabetes, and other chronic diseases in obese individuals. A combination of calorie restricted diet, regular physical activity, and behavioral modification with or without pharmacotherapy has been utilized to treat obesity; however, a significant weight loss of 10 to 15% is rarely achieved or sustained9. For morbid obesity, bariatric surgery is the only treatment option with sustainable weight loss. However, some patients with moderately increased BMI do not qualify for bariatric surgery or prefer less invasive treatment modalities. In these patients, an intragastric balloon (IGB) can help them adhere to lifestyle modification, preventing the need for bariatric surgery. IGB treatment, in addition to lifestyle modification, has been shown to be an effective short-term modality for weight loss.

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Sajani Shah, MD

Study details

Inclusion Criteria
  • BMI 30 kg/m2 and 40 kg/m2
  • Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study
  • At least one unsuccessful attempt at weight loss, such as self-administered, commercial or medically supervised lifestyle therapy program attempted within the 24 months preceding enrollment
Exclusion Criteria
  • Unable to walk 400 meters (the length of one loop of a track and field race track) without the use of an assistance device (e.g. cane, crutches, walker, wheel chair)
  • Previous bariatric surgery including adjustable gastric band and endoscopic sleeve gastroplasty, or likely to undergo bariatric surgery during the study period
  • Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
Study Requirements

The patient will be deemed qualified for the study by the PI, who will then consent them to the study. They will be randomized at the time their eligibility is confirmed. Then a history will be collected and a physical exam will be done. Vitals, height/weight and bmi will also be collected. The patient will have the opportunity to swallow an Allurion practice capsule, and if they cannot swallow it, they will be excluded from the study. In this first visit, the patient will also have labs drawn, including a pregnancy test. The patient will also have a barium swallow performed on screening visit to make sure there are no abnormalties in their anatomy. They will fill out several questionnaires outlined in the study schema listed in the beginning. All patients that are randomized to the ABGs will be ordered for a follow up ultrasound, and potentially an x-ray if the ultrasound is inconclusive. The first balloon is placed at 16 weeks, and the second balloon is placed at 24 weeks. All patients in the treatment group, and the control group will take a PPI (proton pump inhibitor). All subjects will be followed through until week 48 and then will exit the study.

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