In a groundbreaking study, one of the largest of its kind in Europe, researchers have evaluated the safety and efficacy of a 12-month intra-gastric balloon (IGB) for the treatment of overweight and obesity. The study, conducted between September 2017 and August 2021, focused on patients receiving the Orbera 365™ IGB, a device that has the potential to revolutionise endoscopic treatments for weight management.
The study included a substantial cohort of 1149 patients, with a significant majority being female (87.13%). The median body mass index (BMI) prior to insertion was 36.30 kg/m². The results revealed a median absolute weight loss of 11.36 kg for all patients, with ongoing sustained weight loss observed until the device’s removal at week 52. Patients with weight recordings at the point of IGB removal exhibited even greater median weight loss (15.88 kg), translating to a percentage total body weight loss of 15.38% and excess weight loss of 53.99%. Importantly, increased patient engagement with post-procedural follow-up was associated with higher weight loss outcomes (p<0.001).
Despite the significant benefits, the study also reported on safety measures. There were 60 total complications (5.22%), with 50 patients requiring balloon removal due to intolerance and only two severe complications (0.17%). Notably, there were eight cases of balloon rupture, emphasising the importance of continued research to improve device durability.
The study concluded that the 12-month IGB demonstrated safety comparable to published literature, confirming its viability as an effective option for long-term weight loss. This is particularly relevant in a global context where rates of overweight and obesity are escalating, affecting around 2 billion people worldwide. In England alone, 68.6% of men and 59.0% of women are classified as overweight or obese.
The Orbera 365™ IGB builds on the success of its predecessor, the 6-month Orbera™ balloon, offering the advantage of remaining in situ for an extended period. The 12-month device has shown promise, achieving approximately 18% total body weight loss in previous studies. This latest research reinforces its safety and efficacy, providing a potential solution for individuals seeking effective weight loss alternatives beyond metabolic and bariatric surgery.
As the study marks a significant milestone in the field. We are the number one provider for gastric balloons in the UK. For those interested in exploring this transformative option further, the call to action is clear – enquire for more information. With the 12-month IGB showing such promise, it could massively help in the battle against obesity, offering a less invasive yet impactful solution for those struggling with weight management.