A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single-center, single-surgeon experience.

BACKGROUND

Elipse™ is the least invasive IGB for weight loss that needs no sedation or endoscopy. It is a swallowable capsule filled with 550 mL of fluid, which stays in the stomach for 16 weeks and is excreted from the gastrointestinal tract. Kuwait is one of the first countries to start using Elipse™ as a weight loss device. This study aims to evaluate the efficacy and safety of Elipse™ intragastric balloon (IGB).

MATERIALS AND METHODS

This is a single-center prospective pilot study of 51 Elipse™ insertions at our clinic. The patients were followed for 4 months to monitor their weight and body mass index (BMI) at 1, 2, and 4 months. Total weight loss, % excess weight loss (%EWL), % total body weight loss (%TBWL), and change in BMI and waist circumference (WC) were recorded at the end of the study. A short survey was administered to evaluate symptoms, complications, and overall satisfaction.

RESULTS

Fifty-one patients participated, of which five had Elipse™ removed because of intolerance. One case vomited the balloon; one had early deflation. The total weight loss was 8.84 kg, %TBWL 10.44%, %EWL 40.84%, change in BMI 3.42 kg/m, and the total WC reduction 8.62 cm. Symptoms after insertion were severe, whereas those during excretion were mild and self-limiting. No serious complications were recorded, and the overall satisfaction was above average.

CONCLUSION

Our data proves that Elipse™ is a safe and effective device for weight loss. Nevertheless, some limitations were observed that need to be overcome for better outcomes. Larger studies are needed to support our findings.