The First Procedureless Gastric Balloon for Weight Loss: Results from a Multi-Center, Prospective Study Evaluating Safety, Efficacy, Metabolic Parameters, and Quality of Life

Ram Chuttani¹, Evzen Machytka², Ioannis Raftopoulos³, Martina Bojkova², Tomas Kupka², Marek Buzga⁴, Andreas Giannakou³, Kandiliotis Ioannis³, Samuel Levy⁵, Shantanu Gaur⁵. ¹Beth Israel Deaconess Medical Center, Harvard Medical School, ²University Hospital Ostrava, ³Iatriko Medical Center, ⁴University of Ostrava, ⁵Allurion Technologies

Background

Traditional gastric balloons for weight loss require endoscopy for placement and removal.  Elipse™ (Allurion Technologies, Wellesley, MA USA) is the first procedureless gastric balloon. The balloon is swallowed, resides in the stomach for 4 months, and is then excreted.

Methods

Each patient swallowed one Elipse™ device, which was filled with 550mL of filling fluid through a thin delivery catheter that was then removed.  Each device was designed to remain in the stomach for 4 months and then reproducibly open and pass. Weight was measured every 2 weeks, and metabolic parameters were assessed at baseline and at trial exit. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire was administered at baseline and trial exit to measure the effects of weight loss on Physical Function (PF), Self-Esteem (SE), Sexual Life (SL), Public Distress (PD), Work (W), and Overall (O).

Results

Thirty-four patients were enrolled with a mean BMI of 34.4 kg/m2. All 34 patients successfully swallowed the Elipse™ device.  As expected with balloon therapy, some patients experienced nausea, vomiting, and abdominal cramps during the first 48 hours.  All adverse events were either self-limiting or resolved with medication.  At 4 months, the mean weight loss was 22lbs, percent total body weight loss was 9.5%, and percent excess weight loss was 37.2%. All balloons were safely excreted. Mean waist circumference and hemoglobin A1c (HgbA1c) were reduced by 8cm and -0.16%, respectively. Improvements were also seen in triglycerides and LDL. At trial exit, IWQOL-Lite mean scores improved across all domains: +13.7, +17.7, +6.0, +7.7, +7.9, and +11.9 for PF, SE, SL, PD, W, and O, respectively. An improvement of greater than 7.7 in any domain is considered statistically significant.

Conclusions

These results demonstrate clinically significant weight loss with Elipse™, the first procedureless gastric balloon. The weight loss observed was similar to that seen in prior studies of endoscopically placed balloons. There were no serious adverse events. In addition, Elipse™ therapy led to a significant improvement in waist circumference, HgbA1c, and overall quality of life.