Endoscopy 2017; 49(02): 154-160
DOI: 10.1055/s-0042-119296
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study

Evzen Machytka
1  Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic
,
Shantanu Gaur
2  Allurion Technologies, Wellesley, Massachusetts, USA
,
Ram Chuttani
3  Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
,
Martina Bojkova
4  Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic
,
Tomas Kupka
4  Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic
,
Marek Buzga
5  Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic
,
Andreas Giannakou
6  Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece
,
Kandiliotis Ioannis
7  Department of Radiology, Iatriko Medical Center, Palaio Faliro, Greece
,
Elisabeth Mathus-Vliegen
8  Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
,
Samuel Levy
2  Allurion Technologies, Wellesley, Massachusetts, USA
,
Ioannis Raftopoulos
6  Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece
9  Comprehensive Weight Loss Institute, Holyoke Medical Center, Holyoke, MA, USA
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Weitere Informationen

Publikationsverlauf

submitted09. April 2016

accepted after revision08. September 2016

Publikationsdatum:
12. Dezember 2016 (online)

Abstract

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life.

Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit.

Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains.

Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.

ClinicalTrials.gov identifier: NCT 02802007.