Elipse Balloon is a novel weight loss device not requiring endoscopy or sedation for either placement or removal. It is designed to deflate 16 weeks following placement.
Determine the Elipse treatment short-term effects on weight loss and metabolic syndrome (MS). Retrospective analysis of prospectively entered data from the Italian Elipse Group between January 2017 and July 2019
324 patients (59% female) with a mean age of 46 years, mean weight 104 kg and mean BMI of 36.8 kg/m2 were included. After 16 weeks, the mean weight loss was 14.3 kg with a ΔBMI of 5 kg/m2, TBWL was 13.75%, EWL was 43.3%. At 1-year follow-up, TBWL was 10.1%, EWL was 31 % with a ΔBMI of 3.7 kg/m2 from baseline. The overall incidence of MS at baseline, 4 months and 1 year after balloon elimination, was 43.5%, 15.7% and 17.9% respectively. Four balloons (1.3%) were removed early due to intolerance. One empty balloon (0.3%) was passed in stools and another one was vomited, both after 12 weeks. AEs included nausea (59%), regurgitation (45%), abdominal pain (35.1%) and vomiting (12%). No bowel obstruction or other SAEs were recorded.
Elipse appears to be safe and effective, inducing a TBWL of 13.75% at 4 months and 10.1% at 1-year-follow-up (73% sustained weight-loss), together with a significant sustained reduction in the MS incidence, in the absence of SAEs.