title: Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study.
abstract: Background and study aimsConventional 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.MethodsEach 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.Results34 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.ConclusionThese 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.
authors.affiliation: Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic.
authors.forename: Evzen
authors.initials: E
authors.lastname: Machytka
authors.affiliation: Allurion Technologies, Wellesley, Massachusetts, USA.
authors.forename: Shantanu
authors.initials: S
authors.lastname: Gaur
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Ram
authors.initials: R
authors.lastname: Chuttani
authors.affiliation: Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic.
authors.forename: Martina
authors.initials: M
authors.lastname: Bojkova
authors.affiliation: Internal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic.
authors.forename: Tomas
authors.initials: T
authors.lastname: Kupka
authors.affiliation: Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
authors.forename: Marek
authors.initials: M
authors.lastname: Buzga
authors.affiliation: Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece.
authors.forename: Andreas
authors.initials: A
authors.lastname: Giannakou
authors.affiliation: Department of Radiology, Iatriko Medical Center, Palaio Faliro, Greece.
authors.forename: Kandiliotis
authors.initials: K
authors.lastname: Ioannis
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Mathus-Vliegen
authors.affiliation: Allurion Technologies, Wellesley, Massachusetts, USA.
authors.forename: Samuel
authors.initials: S
authors.lastname: Levy
authors.affiliation: Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece.|Comprehensive Weight Loss Institute, Holyoke Medical Center, Holyoke, MA, USA.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Raftopoulos
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015992:Body Mass Index; D004106:Dilatation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D015905:Gastric Balloon; D009765:Obesity / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D011788:Quality of Life; D016896:Treatment Outcome; D015431:Weight Loss