A149 Procedureless Gastric Balloon for Weight Loss: Multi-Center Experience in 1623 Consecutive Patients

Abstract

[eng] Background The Elipse¿ Balloon has emerged as a novel, non-endoscopic option for patients with obesity or overweight. It is swallowed in an outpatient setting and filled with 550ml of fluid. After 4 months of gastric residence, the balloon spontaneously empties and is excreted naturally. Objective: To evaluate the safety and efficacy of the current generation Elipse Balloon in a large, multicenter, international population. Methods Outcomes data from 1623 consecutive Elipse Balloon patients (1171F/506M) treated in 19 centers across 7 countries were pooled for analysis. Nutritional counseling was provided. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. Results At placement, mean age was 39.2±12 yrs, mean weight 94±18.6 kg and mean BMI 34.2±5.4 kg/m2. Triglycerides, LDL cholesterol and HgB A1C were 144.6±70.8 mg/dl, 133.2±43.8 mg/dl and 5.1±1.2% respectively. After 4 months, TBWL was 13.6±5.7%. Mean WL, mean EWL and mean BMI reduction were 12.9±6.5 kg, 55.8±1.1% and 4.9±3.3 kg/m2 respectively. All metabolic parameters improved. 99.9% patients were able to swallow the device with 31.7% needing stylet assistance. Ten (0.62%) empty balloons were vomited and the rest were excreted in stool. Three (0.18%) balloons deflated early. 41 (2.5%) patients had intolerance requiring endoscopic balloon removal. One (0.06%) patient developed esophagitis. One (0.06%) had gastric perforation requiring surgery. There were no small bowel obstructions or any other serious complications. Conclusion The Elipse¿ Balloon demonstrated an excellent safety profile with no small bowel obstructions. The balloon also exhibited remarkable efficacy with 13.6% TBWL and improvement across all metabolic parameters.