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Multicenter Study
. 2020 Sep;30(9):3354-3362.
doi: 10.1007/s11695-020-04539-8.

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
Affiliations
Multicenter Study

The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients

R Ienca et al. Obes Surg. 2020 Sep.

Erratum in

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: Allurion balloon; Elipse balloon; Intragastric balloon; Multicenter study; Non-endoscopic balloon; Obesity; Overweight; Procedureless; Swallowable balloon; Weight loss.

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Conflict of interest statement

Roberta Ienca and Michele Rosa are consultants for Allurion; F. Badiuddin is an advisor for Allurion. The authors declare that there are no other conflicts of interest for this study.

Figures

Fig. 1
Fig. 1
The Elipse® balloon
Fig. 2
Fig. 2
Elipse: Key innovations
Fig. 3
Fig. 3
Mechanism of valve opening
Fig. 4
Fig. 4
The Elipse system: Elipse balloon, Bluetooth® body composition scale, and smartphone app for virtual follow-up
See this image and copyright information in PMC

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