The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal

Abstract

Introduction: The Ellipse intragastric balloon (EIGB) is a new swallowable balloon that does not require endoscopy at insertion or removal. The aim of this study is to investigate the safety of EIGB and its efficiency in weight reduction even after 1 year of expulsion. Method: Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of EIGB in the period between September 2016 and February 2017. The patients were followed up to assess pain, nausea, and vomiting after procedure. As well as, the time of balloon extraction, route of extraction, and weight loss. Results: Total of 112 patients underwent EIGB placement. A 1-year follow-up was obtained on 85% of patients. Mean weight and BMI before the procedure 92.2 kg and 34.3 kg/m2, respectively. One patient had small bowel obstruction. Six patients did not tolerate EIGB and three patients had early deflation. Total weight loss % (TWL%) 10.7, 10.9, and 7.9% at 3, 6, and at date of last follow-up. When data were stratified according to BMI into two groups: group 1 (BMI 27.5–34.9) and group 2 (BMI 35–49), the TWL% for group 1 at 3 months, 6 months, and last day of follow-up are as follows: 10.2%, 10.6%, and 8.8%, while it was 11.5%, 11.2%, and 6.6% for group 2. Conclusion: EIGB are effective, safe, and feasible non-invasive method for weight loss.