Swallowable gastric balloon offers safe, nonendoscopic option for adults with overweight, obesity
LAS VEGAS — Adults with overweight or obesity who received a swallowable gastric balloon that deflates on its own experienced a significant decrease in body weight and cardiometabolic disease markers with few adverse events, according to findings presented at ObesityWeek.
The gastric balloon (Elipse, Allurion Technologies), described as the world’s first procedureless medical device for weight loss, compares well with the weight loss achieved by other longer-duration, endoscopic gastric balloons, Roberta Ienca, MD, a nutritionist physician with Sapienza University in Rome, said during a presentation.
“Elipse is a new, swallowable intragastric balloon that represents an innovative option for weight loss, because it doesn’t require anesthesia or endoscopy,” Ienca said. “The Elipse balloon self-empties at approximately 4 months and passes naturally, and several studies have already demonstrated that Elipse is safe and effective in reducing weight. Although the residence time of Elipse in the stomach is less than other conventional intragastric balloons, the results appear to be comparable.”
In a prospective, nonrandomized, open-label study, Ienca and colleagues analyzed data from 1,770 individuals with overweight or obesity (BMI 27 kg/m²) enrolled at 19 international obesity centers from seven countries in Europe and the Middle East (1,264 women; mean age, 39 years; mean BMI, 34.4 kg/m²). Monthly follow-up visits were live and virtual. For virtual visits, participants used a Bluetooth-enabled body composition analyzer smart scale and received motivational messages from providers. A subset of centers also collected metabolic data.
At 4 months, mean total body weight loss was 14.2% (P < .0001), and mean BMI decrease was 4.9 kg/m² (P < .0001). Metabolic parameters also improved for the group. Between baseline and 4 months, mean HbA1c decreased from 5.1% to 4.8% (P < .0001), mean triglyceride level fell from 145.1 mg/dL to 99.4 mg/dL (P < .0001) and mean LDL cholesterol fell from 133.1 mg/dL to 106.9 mg/dL (P < .0001).
Within the cohort, 95.6% of participants passed the balloon via stool, 0.6% vomited the balloon and 3.6% required endoscopic removal. The most frequently reported adverse event was intolerance (endoscopic removal; 2.9%), followed by early deflation (< 3 months; 0.6%) and spontaneous hyperinflation (0.2%).
“Small bowel obstruction in three patients occurred in 2016 with an earlier version of the device,” Ienca said. “There were no obstructions from 2017 onwards with the introduction of the current-generation device.”
Ienca said the ease of use, low rate of adverse events and potentially lower cost of the balloon may allow wider application of gastric balloon technology in practice for individuals with overweight or obesity.
“The noninvasiveness and virtual follow-up possible with the Elipse program makes this treatment more accessible to all categories of patients,” Ienca said. – by Regina Schaffer
Ienca R, et al. A149. Presented at: ObesityWeek 2019; Nov. 3-7, 2019; Las Vegas.
Disclosure: Ienca reports she serves as a consultant for and has received honoraria from Allurion.