The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients
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ORIGINAL CONTRIBUTIONS
The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients R. Ienca 1 & Mohammed Al Jarallah 2 & Adelardo Caballero 3 & Cristiano Giardiello 4 & Michele Rosa 5 & Sébastien Kolmer 6 & Hugues Sebbag 7 & Julie Hansoulle 8 & Giovanni Quartararo 9 & Sophie Al Samman Zouaghi 10 & Girish Juneja 11 & Sébastien Murcia 12 & Roman Turro 13 & Alberto Pagan 14 & Faruq Badiuddin 15 & Jérôme Dargent 16 & Pierre Urbain 17 & Stefan Paveliu 18 & Rita Schiano di Cola 4 & Corrado Selvaggio 5 & Mohammed Al Kuwari 19
# Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Purpose The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and 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, device performance, and complications. Results Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 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 stylet assistance. 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 requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, 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 improvement across all metabolic parameters. Keywords Multicenter study . Weight loss . Intragastric balloon . Elipse balloon . Obesity . Overweight . Swallowable balloon . Non-endoscopic balloon . Procedureless . Allurion balloon
Introduction The obesity epidemic is now a worldwide phenomenon. Diet and exercise have been ineffective in controlling this epidemic. Bariatric surgery, although effective, has significant associated risks. Minimally invasive techniques, including endoscopically placed gastric balloons, have been introduced to provide a safer alternative for achieving
* R. Ienca [email protected] Extended author information available on the last page of the article
weight loss. The new swallowable gastric balloon, Elipse® (Allurion Technologies, Na
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