Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience.

PURPOSE: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy.

MATERIALS AND METHODS: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2 ). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy.

RESULTS: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2 . Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed.

CONCLUSIONS: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.