부산대학교 도서관

Purpose: The Elipse balloon is a novel, non-endoscopic option for weightloss. It is swallowed and filled with fluid. After 4 months, the balloonself-empties and is excreted naturally. Aim of the study was to evaluate safetyand efficacy of Elipse balloon in a large, multicenter, population.Materials and Methods: Data from 1770 consecutive Elipse balloon patients was analyzed.Data included weight loss, metabolic parameters, ease of placement, deviceperformance, and complications.Results: Baseline patient characteristics were mean age38.8 ± 12, mean weight94.6 ± 18.9 kg, and mean BMI34.4 ± 5.3 kg/m2.Triglycerides were 145.1 ± 62.8 mg/dL, LDLcholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was5.1 ± 1.1%. Four-month results were WL13.5 ± 5.8 kg, %EWL67.0 ± 64.1, BMI reduction 4.9 ± 2.0,and %TBWL 14.2 ± 5.0. All metabolic parameters improved.99.9% of patients were able to swallow the device with 35.9% requiring styletassistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two(2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%)balloons deflated early. There were three small bowel obstructions requiringlaparoscopic surgery. All three occurred in 2016 from an earlier design of theballoon. Four (0.02%) spontaneous hyperinflations occurred. There was one(0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outletobstruction, delayed intestinal balloon transit, and gastric perforation(repaired laparoscopically).Conclusion: The Elipse™ Balloon demonstrated an excellent safety profile.The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvementacross all metabolic parameters.