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Obese patients achieve weight loss with Elipse procedureless gastric balloon

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Obese patients achieved significant weight loss with the Elipse gastric balloon, according to data from a prospective study presented at the Society of American Gastrointestinal and Endoscopic Surgeons 2016 Annual Meeting.

Elipse (Allurion Technologies) is a procedureless gastric balloon that is swallowed, filled with fluid via a catheter, remains in the stomach for 4 months and is then excreted. The device was approved in the European Union in December 2015.

Shantanu Gaur

“While other gastric balloons for weight loss require endoscopy and anesthesia, Elipse is the first procedureless gastric balloon: the balloon is swallowed and excreted 4 months later,” Shantanu Gaur, MD, co-founder and chief scientific officer of Allurion, told Healio Gastroenterology. “The European multi-center trial was designed to assess the feasibility, safety, and efficacy of Elipse in individuals with a BMI between 27 and 40.”

Thirty-four patients (mean BMI, 34.4 kg/m²) successfully swallowed the Elipse device, which was then filled with 550 mL of filling fluid. Researchers weighed patients every 2 weeks, and evaluated the patients’ metabolic parameters and quality of life at the beginning and end of the study.

Some patients experienced nausea, vomiting and abdominal cramps during the first 2 days, and any adverse events that occurred during the study were self-limiting or medically resolved.

“On average, participants in the trial lost 10% of their total body weight, 39% of their excess weight, and 8 cm off their waist,” Gaur said. “In addition, participants reported an improvement in quality of life and 93% would repeat Elipse if given the opportunity. Moreover, there were no serious adverse events.”

At the end of the study, all balloons were safely excreted, mean weight loss was 22 lb, percent total body weight loss was 9.5%, percent excess weight loss was 37.2%, mean waist circumference was reduced by 8 cm and hemoglobin A1c was reduced by 0.16%. Triglycerides and LDL also improved, and quality of life measures improved significantly, including physical function, self-esteem, sexual life, public distress, work and overall quality of life.

“While larger studies are planned for Elipse, these results demonstrate that Elipse can safely achieve clinically meaningful weight loss in an outpatient setting without endoscopy or anesthesia,” Gaur said. – by Adam Leitenberger

Reference:

Chuttani R, et al. Abstract ET012. Presented at: SAGES Annual Meeting; March 16-19, 2016. Boston.

Disclosure: Gaur is employed by Allurion.