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

Abstract

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. 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. 34 patients, with a mean body mass index of 34.8 kg/m, 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. 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.

Recent Advances in Endoscopy

“…A non-endoscopic balloon (Elipse; Allurion, Natick, MA) was reported in a series of 34 patients that had the swallowed balloon inflated to 550 mm and then deflated at 4 months, at which time 10% of the total body weight was lost. 81 This is a new addition to the 2 previously approved endoscopically placed intragastric balloons that are approved in the United States.…”

Endoscopic bariatric and metabolic therapies: Another tool for the management of diabetes and obesity

“…The Elipse balloon stays in place for 4 months, after which it self‐degrades and is excreted through the stool. Two prospective small‐scale single‐center studies demonstrated 10% TBWL at 4 months . A recent multicenter prospective study (n = 135) reported a higher TBWL of 15.1% .…”

“…Two prospective smallscale single-center studies demonstrated 10% TBWL at 4 months. 23,24 A recent multicenter prospective study (n = 135) reported a higher TBWL of 15.1%. 25 The Elipse balloon was also shown to cause a statistically significant reduction in HbA1c and blood pressure, suggesting that it may affect the metabolic syndrome in a shorter amount of time than other IGB designs.…”

“…25 The Elipse balloon was also shown to cause a statistically significant reduction in HbA1c and blood pressure, suggesting that it may affect the metabolic syndrome in a shorter amount of time than other IGB designs. 23 Serious adverse events included early deflation, vomiting the balloon early, and small bowel obstruction requiring laparoscopic enterotomy in a small number of patients. 24,25 Further studies are needed to clarify the safety and efficacy of the Elipse IGB design.…”

Reply to Letter to the Editor in Response to “Elipse Balloon: the Pitfalls of Excessive Simplicity”

“…However, since some IFSO nations do not specify the type of endoluminal procedures performed, we cannot rule out the possibility that the number of Elipse placed in 2016 is underestimated. To the best of our knowledge, some authors reported a small series of patients without any significant complication [2][3][4][5]. However, a recent multicenter, prospective study [6] enrolling a larger population of 135 patients described 1 SBO (0.74%) that required a laparoscopic enterotomy.…”