Shantanu Gaur, MD1, Samuel Levy, MD1, Evzen Machytka, MD2, Bruce Schirmer, MD3, Daniel Jones, MD4, George Blackburn, MD, PhD4, Kathryn Stecco, MD1. 1Allurion Technologies, 2University of Ostrava, 3University of Virginia, 4Beth Israel Deaconess Medical Center
The intragastric balloon (IGB) has been used effectively as a weight loss device for decades. Current generation IGBs require endoscopy for placement and removal and are typically left to reside in the stomach for six months. It is believed that IGBs work by inducing satiety and encouraging portion control.
However, current generation IGBs has several limitations: (1) placement and removal endoscopies require sedation, special training, and equipment, thereby limiting the number of physicians who can deliver the device; (2) high cost and lack of reimbursement reduces patient demand; and (3) patients lost to follow-up are susceptible to IGB deflation, unplanned passage into the gastrointestinal tract, and bowel obstruction.
Elipse™ (Allurion Technologies, Wellesley, MA, USA) is a swallowed, self-emptying, and excreted IGB that addresses these limitations. The Elipse™ balloon is enclosed inside a capsule and is attached to a thin, flexible tube long enough to remain outside the patient’s mouth once it is swallowed. After swallowing, Elipse™ can be filled with 550mL of liquid in less than ten minutes without the use of anesthesia. When filling is complete, the tube is removed by pulling it back out through the patient’s mouth.
Elipse™ is designed to remain in the stomach for 3 months at which point a valve opens, allowing Elipse™ to empty. The empty device is small, flexible, and smooth and soon passes out of the stomach and is excreted through the gastrointestinal tract.
Since Elipse™ does not require endoscopy or anesthesia, it can be administered by most bariatric surgeons with minimal disruption to their practice. Moreover, Elipse™ can be offered to patients who either do not qualify or do not want surgery and who otherwise would have no other options.
Both in vitro and in vivo pre-clinical testing on the Elipse™ have been reported. In addition, a first-in-human pilot trial in 8 patients has been completed, demonstrating the feasibility and safety of Elipse™ treatment. In particular, the pilot trial demonstrated that Elipse™ can be swallowed, filled in less than 15 minutes, and excreted safely through the GI tract at the end of therapy and induce weight loss in all patients treated. A multi-center trial evaluating the efficacy and safety of Elipse™ is ongoing.
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